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Baxter Healthcare Corp.
Baxter Healthcare Corp.: 86 FDA recall reports
Every medical device recall the FDA has published for Baxter Healthcare Corp.. The fault, and how the agency graded it.
86Reports
11Class I
0Ongoing
2017-09-20Most recent
11 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Z-3133-2017 · Class II · reported 2017-09-20 · Terminated
- Why it was recalled
- The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette.
- Product
- Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
- Where it went
- nationwide, Canada
- How much
- 164,700 units
V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LL
Z-0672-2017 · Class II · reported 2016-12-07 · Terminated
- Why it was recalled
- A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Case Assembly in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely.
- Product
- V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended. Product Code 35701 is a replacement assembly that is shipped to customers for self-repair of the Spectrum Infusion Pump. It is not a registered finished good.
- Where it went
- Nationwide Distribution, Puerto Rico and Canada
- How much
- 439 units
sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 3570
Z-0670-2017 · Class II · reported 2016-12-07 · Terminated
- Why it was recalled
- A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely.
- Product
- sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended.
- Where it went
- Nationwide Distribution, Puerto Rico and Canada
- How much
- 5,976 units (US: 5972, Canada: 4)
Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BA
Z-0671-2017 · Class II · reported 2016-12-07 · Terminated
- Why it was recalled
- A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely.
- Product
- Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Baxter Healthcare Corporation, Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended.
- Where it went
- Nationwide Distribution, Puerto Rico and Canada
- How much
- 15,517 units (US: 9560; Canada: 5957)
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Re
Z-0370-2017 · Class II · reported 2016-11-16 · Terminated
- Why it was recalled
- Potential presence of particulate matter on the blood side of the dialyzer
- Product
- GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.
- Where it went
- Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.
- How much
- 22,656 units
Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile,
Z-2687-2016 · Class II · reported 2016-09-07 · Terminated
- Why it was recalled
- Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.
- Product
- Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case; For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
- Where it went
- Worldwide Distribution - US including FL, GA, IL, KS, KY, MI, MO, NC, ND, OH, PA, SC, TN, TX, WV, Puerto Rico and Internationally to Canada.
- How much
- 15,257 units
1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: B
Z-2609-2016 · Class II · reported 2016-08-31 · Terminated
- Why it was recalled
- In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop, but cannot bypass, the active Initial Drain. This is to mitigate against Unintended Increased Intraperitoneal Volume (IIVP). This can cause serious problems in patients with unrelated a co-morbid condition of ascites.
- Product
- 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
- Where it went
- Worldwide distribution. US nationwide including Puerto Rico; Australia, Canada, New Zealand, and Japan
- How much
- *** 1) Product Codes 5C4471 and 5C4471R: Approximately 48,600 units; *** 2) Product Codes 5C8310 and 5C8310R: Approxiamtely 16,990 units
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product
Z-2533-2016 · Class II · reported 2016-08-24 · Terminated
- Why it was recalled
- Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUARD Peripheral Vascular Patch. Baxter has received reports for intraoperative or postoperative bleeding episodes, which required additional clinical intervention. One report involved a case with a fatal outcome. UPDATE 9/1/2016 Baxter issued a notice retrieving 6 lots of VASCU-GUARD due to the increased postmarketing reports related to intraoperative and postoperative bleeding.
- Product
- Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Sterilized using aseptic processing techniques. The pericardium is procured from cattle originating in the United States. VASC-Guard is chemically sterilized using ethanol and propylene oxide. UPDATE 9/1/2016 Retrieval of devices only includes Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N.
- Where it went
- Nationwide including Puerto Rico, and outside the US to include: Australia, Austria, Finland, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Poland, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, United Kingdom.
- How much
- 32,763 eaches UPDATE 9/1/2016 2,042 eaches
PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
Z-2049-2016 · Class II · reported 2016-07-06 · Terminated
- Why it was recalled
- Presence of leaks near top of the PrismaSate bags
- Product
- PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
- Where it went
- Distributed to Columbia and the following US states: AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI
- How much
- 10,054 units
COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjun
Z-1839-2016 · Class II · reported 2016-06-08 · Terminated
- Why it was recalled
- Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.
- Product
- COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Where it went
- Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
- How much
- 6,804 units
COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjun
Z-1840-2016 · Class II · reported 2016-06-08 · Terminated
- Why it was recalled
- Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.
- Product
- COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Where it went
- Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
- How much
- 6,128 units
COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunc
Z-1838-2016 · Class II · reported 2016-06-08 · Terminated
- Why it was recalled
- Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.
- Product
- COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Where it went
- Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
- How much
- 274 units
GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The Fl
Z-1628-2016 · Class II · reported 2016-05-18 · Terminated
- Why it was recalled
- Instructions for use booklet may puncture the outer Tyvek lid.
- Product
- GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
- Where it went
- Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada
- How much
- 630 units
GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The Flo
Z-1627-2016 · Class II · reported 2016-05-18 · Terminated
- Why it was recalled
- Instructions for use booklet may puncture the outer Tyvek lid.
- Product
- GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
- Where it went
- Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada
- How much
- 315 units
GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage: The Flo
Z-1629-2016 · Class II · reported 2016-05-18 · Terminated
- Why it was recalled
- Instructions for use booklet may puncture the outer Tyvek lid.
- Product
- GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
- Where it went
- Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada
- How much
- 707 units
GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowC
Z-1630-2016 · Class II · reported 2016-05-18 · Terminated
- Why it was recalled
- Instructions for use booklet may puncture the outer Tyvek lid.
- Product
- GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
- Where it went
- Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada
- How much
- 288 units
GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Product Usage: The Flo
Z-1631-2016 · Class II · reported 2016-05-18 · Terminated
- Why it was recalled
- Instructions for use booklet may puncture the outer Tyvek lid.
- Product
- GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
- Where it went
- Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada
- How much
- 118 units
Automated peritoneal dialysis (APD) cycler
Z-1565-2016 · Class II · reported 2016-05-04 · Terminated
- Why it was recalled
- Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations. The tot
- Product
- Automated peritoneal dialysis (APD) cycler
- Where it went
- US Consignee: NY ***Foreign Consignee: Ecuador
- How much
- 10 units
Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s,
Z-0606-2016 · Class II · reported 2016-01-13 · Terminated
- Why it was recalled
- Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
- Product
- Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For the administration of fluids from a container into the patients vascular system through a vascular access device. .
- Where it went
- US Nationwide Distribution and the country of Canada
- How much
- 9600 units
Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Us
Z-0607-2016 · Class II · reported 2016-01-13 · Terminated
- Why it was recalled
- Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
- Product
- Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a medicinal product from one container to another container.
- Where it went
- US Nationwide Distribution and the country of Canada
- How much
- 77,136 units
Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids f
Z-0605-2016 · Class II · reported 2016-01-13 · Terminated
- Why it was recalled
- Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
- Product
- Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a container into the patients vascular system through a vascular access device.
- Where it went
- US Nationwide Distribution and the country of Canada
- How much
- 9264 units
Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) ther
Z-0291-2016 · Class III · reported 2015-11-25 · Terminated
- Why it was recalled
- Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with the noise coming from the device and not the function of it. May delay treatment if changing to a different system.
- Product
- Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
- Where it went
- Nationwide Distribution, District of Columbia, and Puerto Rico.
- How much
- 29355
Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
Z-0194-2016 · Class II · reported 2015-11-11 · Terminated
- Why it was recalled
- Leakage from the inlet port of the 15L Cycler Drainage Bags.
- Product
- Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
- Where it went
- US Distribution and Internationally to Canada.
- How much
- 19,440 units
ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACE
Z-0132-2016 · Class II · reported 2015-10-28 · Terminated
- Why it was recalled
- Potential for a leak at the tubing to luer bond.
- Product
- ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
- Where it went
- Domestic Only
- How much
- 23,600
MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intended for use with Ba
Z-2472-2015 · Class II · reported 2015-09-02 · Terminated
- Why it was recalled
- Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
- Product
- MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.
- Where it went
- Worldwide Distribution - US: Nationwide + American Samoa + District of Columbia + Guam + Northern Mariana Islands + Puerto Rico; *** FOREIGN: Antigua, Argentina, Australia, Bahamas, Barbados, Bermuda, Brazil, Canada, Chile, Colombia, Cuba, Curacao, Dominican Republic, Ecuador, El Salvador, France (New Caledonia), Guatemala, Guyana, Honduras, Hong Kong, India, Indonesia, Jamaica, Japan, Macau, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Suriname, Taiwan, Thailand, Trinidad and Tobago, United Kingdom (Cayman Islands), Uruguay, Venezuela
- How much
- 1,213,833 units
MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with Baxter Locking titanium
Z-2473-2015 · Class II · reported 2015-09-02 · Terminated
- Why it was recalled
- Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
- Product
- MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.
- Where it went
- Worldwide Distribution - US: Nationwide + American Samoa + District of Columbia + Guam + Northern Mariana Islands + Puerto Rico; *** FOREIGN: Antigua, Argentina, Australia, Bahamas, Barbados, Bermuda, Brazil, Canada, Chile, Colombia, Cuba, Curacao, Dominican Republic, Ecuador, El Salvador, France (New Caledonia), Guatemala, Guyana, Honduras, Hong Kong, India, Indonesia, Jamaica, Japan, Macau, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Suriname, Taiwan, Thailand, Trinidad and Tobago, United Kingdom (Cayman Islands), Uruguay, Venezuela
- How much
- 33,474 units
CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers
Z-2474-2015 · Class II · reported 2015-09-02 · Terminated
- Why it was recalled
- Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
- Product
- CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEAL peritoneal dialysis solution.
- Where it went
- Worldwide Distribution - US: Nationwide + American Samoa + District of Columbia + Guam + Northern Mariana Islands + Puerto Rico; *** FOREIGN: Antigua, Argentina, Australia, Bahamas, Barbados, Bermuda, Brazil, Canada, Chile, Colombia, Cuba, Curacao, Dominican Republic, Ecuador, El Salvador, France (New Caledonia), Guatemala, Guyana, Honduras, Hong Kong, India, Indonesia, Jamaica, Japan, Macau, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Suriname, Taiwan, Thailand, Trinidad and Tobago, United Kingdom (Cayman Islands), Uruguay, Venezuela
- How much
- 35,460 units
MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended fo
Z-2471-2015 · Class II · reported 2015-09-02 · Terminated
- Why it was recalled
- Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
- Product
- MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.
- Where it went
- Worldwide Distribution - US: Nationwide + American Samoa + District of Columbia + Guam + Northern Mariana Islands + Puerto Rico; *** FOREIGN: Antigua, Argentina, Australia, Bahamas, Barbados, Bermuda, Brazil, Canada, Chile, Colombia, Cuba, Curacao, Dominican Republic, Ecuador, El Salvador, France (New Caledonia), Guatemala, Guyana, Honduras, Hong Kong, India, Indonesia, Jamaica, Japan, Macau, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Suriname, Taiwan, Thailand, Trinidad and Tobago, United Kingdom (Cayman Islands), Uruguay, Venezuela
- How much
- 260,244 units
The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the c
Z-1536-2015 · Class II · reported 2015-05-06 · Terminated
- Why it was recalled
- Potential for device malfunction resulting in flow when the device should not be flowing
- Product
- The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand.
- Where it went
- Worldwide Distribution - US Distribution to the state of FL., and to the countries of : Belgium, Denmark, Germany, Italy, Japan, Norway, Poland, South Korea, Spain, Sweden and United Arab Emirates.
- How much
- 7,596 patient control modules
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion Syst
Z-1451-2015 · Class II · reported 2015-04-22 · Terminated
- Why it was recalled
- Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. MDL drug dose time in seconds will round to the nearest integer in minutes on the pump dose setup screen (20 sec may show as 1 min on the pump display). The pump will administer drugs as configured. The discrepancy may cause therapy delay or unintended rate of delivery.
- Product
- Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids.
- Where it went
- Worldwide Distribution: US Distribution to states of: CA, CT, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NH, NY, SD, TX, UT, WV, including Puerto Rico and country of: Canada.
- How much
- 58 MDLs
Showing the 30 most recent of 86. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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