Device product
BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
Z-2252-2024
Product summary
- Firm
- Synergetics Inc
- Event
- Event 94793
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 2 units
- Official record key
device-enforcement:Z-2252-2024
Official wording
Reason: Sterilization certificates could not be validated by the supplier
Code information: UDI/DI 20841305107551, Lot Number P63044983R
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Sterilization certificates could not be validated by the supplier