RecallDepth

Medtronic Vessel Cannulae: a) DLP 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP 3 mm Vessel Cannula Blunt Tip, Model Number 30003

Company
Medtronic Perfusion Systems
Recall Initiated
March 19, 2024
Posted
May 10, 2024
Recall Number
Z-1799-2024
Quantity
5719 units
Firm Location
Brooklyn Park, MN

Reason for Recall

Potential for unsealed sterile packing.

Distribution

Worldwide distribution.

Lot / Code Info

a) Model Number 30004, GTIN 00613994646156, Lot Numbers: 2023041305; a) Model Number 30004, GTIN 00673978179841, Lot Numbers: 2023041300; a) Model Number 30004, GTIN 20613994646150, Lot Numbers: 2023041300, 2023041305, 202306C194; b) Model Number 30003, GTIN 20613994646174, Lot Numbers: 2023041298, 202306C221

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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