Z-3182-2024Class II

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

Name: Z-3182-2024 HAWK Advanced Hypothermia Management Set, Item Number: 59-320
Creator: Safeguard US Operating LLC
Published: 2024-08-27
License: https://open.fda.gov/license/

Safeguard US Operating LLC / initiated 2024-08-27 / Open, Classified / root cause: manufacturing process

FDA source

Safeguard US Operating LLC began a recall of HAWK Advanced Hypothermia Management Set, Item Number: 59-320 on 2024-08-27. FDA classified it as Class II and gives the reason as "Incorrect expiration date". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3182-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-27
Posted: 2024-09-19
Recalling firm: Safeguard US Operating LLC
Product: HAWK Advanced Hypothermia Management Set, Item Number: 59-320
Product code: IMD Pack, Hot Or Cold, Disposable
Reason for recall: Incorrect expiration date.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Safeguard US Operating notified customers via letters sent on 08/27/2024. Customers were instructed to remove the Convenience Kits from all points of use and return to Safeguard US Operating LLC for label correction of the HAWK component. Also complete the attached Recall Acknowledgement and Receipt Form and return it to Safeguard US Operating LLC per the instructions on the form. Distributors were instructed to carry out the recall to the consumer/user level and to identify customers who received the product and notify them of the recall, including a copy of the letter to enhance notification.
Quantity in commerce: 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.
Product codes and lots: Item Number: 59-320; Lot Numbers: PBO0003797, PBO0003811, PBO0004032, PBO0004315, PBO0004580.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3182-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3181-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19
Z-3182-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19
Z-3183-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19

Product code IMD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)