FDAClass IIMay 22, 2024

Medtronic Tourniquet Sets: a) DLP¿ 5.5 in recall

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

Why was Medtronic Tourniquet Sets: a) DLP¿ 5.5 in recalled?

Potential for unsealed sterile packing.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

a) Model Number 79004, GTIN 20613994576389, Lot Numbers: 2023081324; b) Model Number 79009, GTIN 20613994576457, Lot Numbers: 2023041000, 2023041384, 202305C235

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
Recalling firm
Medtronic Perfusion Systems
Quantity
1760 units
Distribution
Worldwide distribution.
Recall date
May 22, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls