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Custom Healthcare Systems Recalls
33 recalls on record · February 13, 2013 to February 5, 2020 · Medical Devices
Recalls by year
13
15
18
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 5, 2020Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
Hazard: 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.
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GO
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGIN
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
October 31, 2018Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product Number: B9-15934B
Hazard: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility