Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001
This recall is currently active, issued May 10, 2024. It was issued by Medtronic Perfusion Systems.
- Company
- Medtronic Perfusion Systems
- Recall Initiated
- March 19, 2024
- Posted
- May 10, 2024
- Recall Number
- Z-1796-2024
- Quantity
- 7935 units
- Firm Location
- Brooklyn Park, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for unsealed sterile packing.
Distribution
Worldwide distribution.
Lot / Code Info
GTIN 00613994575319, Lot Numbers: 2023041320, 2023041323; GTIN 00673978180465, Lot Numbers: 2023041316, 2023041323; GTIN 20613994575313, Lot Numbers: 2023041316, 2023041318, 2023041320, 2023041323, 202305C146, 202305C154
Root Cause
Process control
Action Taken
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.