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Custom Healthcare Systems, Inc.
Custom Healthcare Systems, Inc.: 33 FDA recall reports
Every medical device recall the FDA has published for Custom Healthcare Systems, Inc.. The fault, and how the agency graded it.
33Reports
0Class I
0Ongoing
2020-02-05Most recent
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.
Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
Z-0863-2020 · Class II · reported 2020-02-05 · Terminated
- Why it was recalled
- A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did NOT show that the Medical Convenience Kit contained LATEX.
- Product
- Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
- Where it went
- US Distribution to IL.
- How much
- 240 kits
CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623
Z-0244-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 50 units
CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000
Z-0261-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 48 units
CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B
Z-0243-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 150 units
CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664
Z-0254-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 48 units
CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B
Z-0260-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 24 units
CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C
Z-0252-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 72 units
CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635
Z-0247-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 100 units
CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400
Z-0268-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 300 units
CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112
Z-0267-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 4500 units
CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF
Z-0266-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECIALTY XL, XLONG
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 72832 units
CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B
Z-0259-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 1250 units
CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02
Z-0250-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 630 units
CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591
Z-0257-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 150 units
CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914
Z-0248-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 50 units
CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669
Z-0256-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 50 units
CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP
Z-0245-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 30 units
CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000
Z-0251-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 250 units
CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD,
Z-0242-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- (1) 750 units (2) 200 units
CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685
Z-0253-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 80 units
CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201
Z-0241-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 40 units
CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
Z-0246-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 160 units
CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914
Z-0262-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 100 units
CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520
Z-0255-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 150 units
CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L
Z-0264-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 7200 units
CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 123
Z-0265-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 89 units
CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product Number: B9-15934B
Z-0240-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product Number: B9-15934B
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 200 units
CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884
Z-0263-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 60 units
(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenienc
Z-0249-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- (1) 180 units (2)180 units
CHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538
Z-0258-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Product
- CHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538
- Where it went
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- How much
- 150 units
Showing the 30 most recent of 33. 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.
← All device recalls