Recall Z-3120-2024 ยท OJK Eye Tray
MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B; b) AMB VITRECTOMY, Pack Number DYNJ59921BH; c) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923B; d) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923BH; e) AMB CUSTOM EYE, Pack Number DYNJ59924B; f) AMB CUSTOM EYE, Pack Number DYNJ59924BH; g) CATARACT-30843, Pack Number DY
| Date | Sep 11, 2024 (initiated Jun 27, 2024) |
| Status | Open, Classified |
| Reason | XXX |
| Root cause | Process control |
| Action | Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 06/27/2024 via US mail and email. The notice explained the problem with the device, potential risk to the patient, and requested the consignee immediately check their stock for the affected item number and the affected lot numbers and destroy any affected inventory. Distributors were directed to notify their customers of the recall and request the affected products be destroyed. For questions: contact the Recall Department at 866-359-1704 or recalls@medline.com. |
| Quantity | 720 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.