Recall Z-0153-2025 ยท OFT Spinal Epidural Anesthesia Kit
MEDLINE INDUSTRIES, LP - Northfield
Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A
| Date | Oct 23, 2024 (initiated Sep 4, 2024) |
| Status | Open, Classified |
| Reason | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed. |
| Root cause | Under Investigation by firm |
| Action | Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees. |
| Quantity | 320 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.