BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
Recall
- Recall Number
- Z-2254-2024
- Event Number
- 94793
- Firm
- Synergetics Inc
- FEI Number
- 1000119053
- Product Code
- KDD
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- June 12, 2024
- Posted
- July 11, 2024
- Address
- 3845 Corporate Centre Dr, O Fallon, MO, 63368-8678
Description
BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
Sterilization certificates could not be validated by the supplier
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).
US Nationwide
35 units