Custom Healthcare Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
33
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0863-2020Class IICustom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kitDecember 20, 2019
Z-0250-2019Class IICHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02August 13, 2018
Z-0255-2019Class IICHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520August 13, 2018
Z-0258-2019Class IICHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538August 13, 2018
Z-0265-2019Class IICHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICALAugust 13, 2018
Z-0260-2019Class IICHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425BAugust 13, 2018
Z-0264-2019Class IICHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050LAugust 13, 2018
Z-0253-2019Class IICHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685August 13, 2018
Z-0257-2019Class IICHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591August 13, 2018
Z-0240-2019Class IICHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product Number: B9-15934August 13, 2018
Z-0266-2019Class IICHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL,August 13, 2018
Z-0248-2019Class IICHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914August 13, 2018
Z-0262-2019Class IICHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914August 13, 2018
Z-0252-2019Class IICHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375CAugust 13, 2018
Z-0267-2019Class IICHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112August 13, 2018
Z-0259-2019Class IICHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481BAugust 13, 2018
Z-0249-2019Class II(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom August 13, 2018
Z-0251-2019Class IICHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000August 13, 2018
Z-0256-2019Class IICHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669August 13, 2018
Z-0242-2019Class IICHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2August 13, 2018