Recall Z-0158-2023 ยท OJK Eye Tray
MEDLINE INDUSTRIES, LP - Northfield
BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgical procedures.
| Date | Nov 1, 2022 (initiated Sep 30, 2022) |
| Status | Open, Classified |
| Reason | Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal. |
| Root cause | Under Investigation by firm |
| Action | Medline disseminated MEDICAL DEVICE RECALL notice by US mail on 09/30/2022, The notices explained the issue and requested the following: "REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. The login for completing the response form i |
| Quantity | 300 kits |
| Distribution | US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.