Z-0242-2019 Class II Terminated
FDA device recall Z-0242-2019 was initiated by Custom Healthcare Systems, Inc. on August 13, 2018 and is designated Class II. Reason for recall: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility The recall status is terminated (terminated August 1, 2022). Affected quantity: (1) 750 units (2) 200 units.
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) 750 units (2) 200 units
Product Description
CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502
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:72018 Exp. Date: 7/1/2021 (2) Lot number: 71118 Exp. Date: 7/1/2021