Recall Z-1810-2025 ยท OJG Neurological Tray
MEDLINE INDUSTRIES, LP - Northfield
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
| Date | May 31, 2025 (initiated Apr 22, 2025) |
| Status | Open, Classified |
| Reason | Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate. |
| Root cause | Nonconforming Material/Component |
| Action | On April 22, 2025, the firm notified customers of the recall through letters titled Immediate Action Required Voluntary Medical Device Recall. Customers were instructed to identify and quarantine all affected product on hand. Customers are to submit a response form to the recalling firm. Upon receipt of the response firm, Medline will provide the customer with over-labels to place on affected inventory, which will include instructions for staff to remove and discard the affected component prior to using the kit. Distributors should notify downstream customers/accounts of this recall. If you |
| Quantity | 1853 total |
| Distribution | US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213481 | Medline General Surgery Tray Medline Industries, Inc., May 24, 2022 |