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Open, Classified

Medtronic Tourniquet Sets: a) DLP 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP 7 in (17.8 cm) Tourniquet Kit, Model Number 79009

FDA Recall Z-1798-2024 · Posted 2024-05-10

Recalling FirmMedtronic Perfusion Systems
Recall StatusOpen, Classified
Product CodeGDJ
Date Initiated2024-03-19
Product Quantity1760 units

Reason for Recall

Potential for unsealed sterile packing.

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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