Recall Z-1798-2024— Medtronic Perfusion Systems

Class II · Ongoing

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2024-03-19. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: Potential for unsealed sterile packing..

Recalling firm
Medtronic Perfusion Systems
Classification
Class II
Status
Ongoing
Initiated
2024-03-19
Firm location
Brooklyn Park, MN, United States

Product description

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

Reason for recall

Potential for unsealed sterile packing.

Data sourced from openFDA. This site is unofficial and independent of the FDA.