Custom Healthcare Systems, Inc.

Complete recall history across all FDA and CPSC categories — 33 total recalls

Custom Healthcare Systems, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (33)

FDA medical device enforcement actions by Custom Healthcare Systems, Inc.

Date Product Reason Class
Dec 20, 2019 Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use... A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical... Class II
Aug 13, 2018 CHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538 Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-1... Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884 Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) P... Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 12... Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Numb... Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520 Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914 Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178 Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201 Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956... Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Produ... Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000 Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Num... Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669 Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914 Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591 Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02 Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UN... Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-... Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112 Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: Y... Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635 Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664 Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number... Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000 Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Aug 13, 2018 CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product... Convenience kits were sealed in immediate Tyvek pouches using incorrect speci... Class II
Nov 5, 2014 Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr ... An INCORRECT item number is packed within the OUTSIDE "PIGGYBACKED" PACKAGE. ... Class II
Nov 26, 2012 Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag,... Surgical procedure trays are packed with pharmaceuticals for injection that m... Class II
Nov 26, 2012 Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in... Surgical procedure trays are packed with pharmaceuticals for injection that m... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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