Recall Z-0783-2025 ยท FDE Laparoscopy Kit
MEDLINE INDUSTRIES, LP - Northfield
Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A; 4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648F; 6) DIEP FLAP, REF DYNJ66867A; 7) KIT FREE FLAP MOSES, REF DYNJ905366A; 8) FREE FLAP, REF DYNJ905634B; 9) ROBOTIC THORA
| 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 | 943 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.