Recall Z-0124-2025 ยท OEZ Cardiovascular Procedure Kit
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840
| Date | Oct 17, 2024 (initiated Aug 28, 2024) |
| Status | Open, Classified |
| Reason | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000. |
| Root cause | Under Investigation by firm |
| Action | Medline issued an UREGENT MEDICAL DEVICE NOTIFICATION to its consignees on 08/28/2024 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the consignee quarantine the product and response to obtain labeling to be placed on the affected inventory. Distributors are directed to notify those to whom they shipped the affected product. |
| Quantity | 22 kits |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.