Device product
(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269
Z-0249-2019
Product summary
- Event
- Event 81179
- Status
- Terminated
- Classification
- Class II
- Quantity
- (1) 180 units (2)180 units
- Official record key
device-enforcement:Z-0249-2019
Official wording
Reason: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information: (1)Lot number: 52418, 51418 Exp. Date: 5/1/2021 (2) Lot Number:51418 Exp Date: 5/1/2021
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