FDA Recall
Open, Classified
Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001
Recall: Z-1796-2024
·
Initiated March 19, 2024
Recall
- Recall Number
- Z-1796-2024
- Event Number
- 94274
- Firm
- Medtronic Perfusion Systems
- FEI Number
- 1000116158
- Product Code
- DWF
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- March 19, 2024
- Posted
- May 10, 2024
- Address
- 7611 Northland Dr N, Brooklyn Park, MN, 55428-1088
Description
Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001
Reason
Potential for unsealed sterile packing.
Action
Medtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties. For questions, the consignee was directed to contact their Medtronic field representative.
Distribution
Worldwide distribution.
Quantity
7935 units