BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)

FDA device recall Z-2251-2024 · posted 2024-07-11 · Open, Classified

Recall details

Recalling firm

Synergetics Inc

Reason for recall

Sterilization certificates could not be validated by the supplier

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).

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KDD

Quantity affected

14 units

Distribution

US Nationwide

Date initiated

2024-06-12

Date posted

2024-07-11

Location

O Fallon, MO