Home / Recalls / Custom Healthcare Systems, Inc. / Z-0249-2019

Z-0249-2019 Class II Terminated

Recalled by Custom Healthcare Systems, Inc. — Richmond, VA

Recall Details

Product Type
Devices
Report Date
October 31, 2018
Initiation Date
August 13, 2018
Termination Date
August 1, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
(1) 180 units (2)180 units

Product Description

(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269

Reason for Recall

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

Distribution Pattern

Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,

Code Information

(1)Lot number: 52418, 51418 Exp. Date: 5/1/2021 (2) Lot Number:51418 Exp Date: 5/1/2021

Other recalls by Custom Healthcare Systems, Inc.

  • Z-0863-2020 Class II — Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. (December 20, 2019)
  • Z-0248-2019 Class II — CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914 (August 13, 2018)
  • Z-0240-2019 Class II — CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Prod (August 13, 2018)
  • Z-0258-2019 Class II — CHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538 (August 13, 2018)
  • Z-0265-2019 Class II — CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231- (August 13, 2018)
  • Z-0250-2019 Class II — CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02 (August 13, 2018)
  • Z-0251-2019 Class II — CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000 (August 13, 2018)
  • Z-0255-2019 Class II — CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520 (August 13, 2018)
  • Z-0266-2019 Class II — CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150 (August 13, 2018)
  • Z-0262-2019 Class II — CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914 (August 13, 2018)