Custom Healthcare Systems, Inc.

FDA Regulatory Profile

Custom Healthcare Systems, Inc. appears in FDA public data with 33 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0863-2020, Class II) was initiated on December 20, 2019.

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-0240-2019Class IICHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product Number: B9-15934August 13, 2018
Z-0253-2019Class IICHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685August 13, 2018
Z-0256-2019Class IICHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669August 13, 2018
Z-0254-2019Class IICHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664August 13, 2018
Z-0261-2019Class IICHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000August 13, 2018
Z-0244-2019Class IICHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623August 13, 2018
Z-0252-2019Class IICHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375CAugust 13, 2018
Z-0268-2019Class IICHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400August 13, 2018
Z-0267-2019Class IICHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112August 13, 2018
Z-0245-2019Class IICHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCPAugust 13, 2018
Z-0246-2019Class IICHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178August 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-0260-2019Class IICHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425BAugust 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
Z-0247-2019Class IICHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635August 13, 2018
Z-0259-2019Class IICHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481BAugust 13, 2018
Z-0258-2019Class IICHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538August 13, 2018
Z-0250-2019Class IICHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02August 13, 2018
Z-0248-2019Class IICHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914August 13, 2018