RecallDepth

Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001

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

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.

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