BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
This recall is currently active, issued July 11, 2024. It was issued by Synergetics Inc.
- Company
- Synergetics Inc
- Recall Initiated
- June 12, 2024
- Posted
- July 11, 2024
- Recall Number
- Z-2252-2024
- Quantity
- 2 units
- Firm Location
- O Fallon, MO
- Official Source
- View on FDA website ↗
Reason for Recall
Sterilization certificates could not be validated by the supplier
Distribution
US Nationwide
Lot / Code Info
UDI/DI 20841305107551, Lot Number P63044983R
Root Cause
Under Investigation by firm
Action Taken
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 those to whom you have distributed the product by forwarding this letter with the recall acknowledgement form. For questions or need any other support with our products, reach out to your Bausch + Lomb sales representative or our customer service team at (800-338-2020).