Recall Z-0794-2025 ยท OJH Orthopedic Tray
MEDLINE INDUSTRIES, LP - Northfield
Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3) CRANIOFACIAL CDS, REF CDS780102L; 4) CRANIOFACIAL CDS, REF CDS780102M; 5) CRANIOTOMY CDS-LF, REF CDS780105K; 6) CRANIOTOMY CDS-LF, REF CDS780105L; 7) CRANIOTOMY CDS-LF, REF CDS780105M; 8) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 9) CRANIOTOMY CDS, REF CDS780166Q; 10) A
| Date | Dec 30, 2024 (initiated Nov 21, 2024) |
| Status | Open, Classified |
| Reason | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination. |
| Root cause | Nonconforming Material/Component |
| Action | Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email. The notice explained the issue, potential risk to health, and requested that the affected product be quarantined. Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit. |
| Quantity | 474300 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of UAE, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.