FDA Recall
Open, Classified
MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840
Recall: Z-0124-2025
·
Initiated August 28, 2024
Recall
- Recall Number
- Z-0124-2025
- Event Number
- 95393
- Firm
- MEDLINE INDUSTRIES, LP Northfield
- FEI Number
- 1417592
- Product Code
- OEZ
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- August 28, 2024
- Posted
- October 17, 2024
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753
Description
MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840
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.
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.
Distribution
US Nationwide distribution.
Quantity
22 kits