Recall Z-1646-2023 ยท OJH Orthopedic Tray
MEDLINE INDUSTRIES, LP - Northfield
Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.
| Date | May 26, 2023 (initiated Apr 21, 2023) |
| Status | Open, Classified |
| Reason | The kits were damaged by water. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued the recall letter dated 4/21/2023 via email on 4/21/2023. The letter informed the customer the packs were exposed to water, potentially affecting the sterility of the item, and that they should be destroyed for credit. The consignee was requested to immediately check their stock for the affected item number and the lot numbers listed on the recall portal. A link was provided to access the response form to list the quantity of affected product in inventory. Upon completion of the form, the consignee was to destroy the affected product. If the consignee is a distri |
| Quantity | 342 packs (114 packs/product) |
| Distribution | Distribution was made to California. There was no foreign/government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.