Z-0267-2019 Class II Terminated
FDA device recall Z-0267-2019 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: 4500 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
- 4500 units
Product Description
CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112
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
Lot Number: W72118 Exp. date: 7/1/2021