Device product
BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
Z-2254-2024
Product summary
- Firm
- Synergetics Inc
- Event
- Event 94793
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 35 units
- Official record key
device-enforcement:Z-2254-2024
Official wording
Reason: Sterilization certificates could not be validated by the supplier
Code information: UDI/DI 20841305107612, Lot Number P62764970R
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Sterilization certificates could not be validated by the supplier