FDAClass IISeptember 25, 2024

HAWK Advanced Hypothermia Management Set recall

HAWK Advanced Hypothermia Management Set, Item Number: 59-320

Why was HAWK Advanced Hypothermia Management Set recalled?

Incorrect expiration date.

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?

Item Number: 59-320; Lot Numbers: PBO0003797, PBO0003811, PBO0004032, PBO0004315, PBO0004580.

Product
HAWK Advanced Hypothermia Management Set, Item Number: 59-320
Recalling firm
Safeguard US Operating LLC
Quantity
408 units
Distribution
US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, NC, NM, NY, OK, OR, RI, TX, VA, WA, WI.
Recall date
September 25, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls