Recall Z-2253-2024 ยท KDD Kit, Surgical Instrument, Disposable
Synergetics Inc
BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)
| Date | Jul 11, 2024 (initiated Jun 12, 2024) |
| Status | Open, Classified |
| Reason | Sterilization certificates could not be validated by the supplier |
| Root cause | Under Investigation by firm |
| Action | Bausch + Lomb issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL notice to its consignees on 05/12/2024 via FedEx. The notice explained the issue, potential hazard, and requested the following: Required actions: 1. Immediately review your inventory and isolate the affected products to prevent unintended use. Please complete and submit the attached Recall Acknowledgement Form that has instructions regarding what to do with product on-hand. You will receive a credit for any returned or destroyed kits. 2. If you have further distributed or transferred the affected product, identify and notify |
| Quantity | 116 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.