MEDLINE OPEN HEART, REF DYNJ904261B
This recall is currently active, issued October 17, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- August 28, 2024
- Posted
- October 17, 2024
- Recall Number
- Z-0122-2025
- Quantity
- 30 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide distribution.
Lot / Code Info
UDI/DI 40193489479530 (case), 10193489479539 (each), Lot Numbers: 23LBR364
Root Cause
Under Investigation by firm
Action Taken
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.