Recall Z-0178-2025 ยท OJK Eye Tray
MEDLINE INDUSTRIES, LP - Northfield
Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK, REF DYNJ24573K; 4) EYE PACK, REF DYNJ30327A; 5) BASIC CATARACT PACK, REF DYNJ36868F; 6) BASIC RETINA PACK, REF DYNJ40811A; 7) OPHTHALMOLOGY PACK CKHA-LF, REF DYNJ41769A; 8) CATARACT PACK WRO-LF, REF DYNJ41861; 9) EYE PACK, REF DYNJ43911; 10) PHACO PACK,
| Date | Oct 23, 2024 (initiated Sep 4, 2024) |
| Status | Open, Classified |
| Reason | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed. |
| Root cause | Under Investigation by firm |
| Action | Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees. |
| Quantity | 27,906 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.