Device product
CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL
Z-0265-2019
Product summary
- Event
- Event 81179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 89 units
- Official record key
device-enforcement:Z-0265-2019
Official wording
Reason: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information: Lot Number: :W72118 Exp Date:7/1/2021
Distribution pattern: Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
Derived failure modes
-
Unknown
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility