HAWK Hypothermia Set (Safeguard) – Incorrect Expiration (2024)
Incorrect expiration date may cause potential inventory management issues.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HAWK Advanced Hypothermia Management Set, Item Number: 59-320
Brand
Safeguard US Operating LLC
Lot Codes / Batch Numbers
Item Number: 59-320, Lot Numbers: PBO0003797, PBO0003811, PBO0004032, PBO0004315, PBO0004580.
Products Sold
Item Number: 59-320; Lot Numbers: PBO0003797, PBO0003811, PBO0004032, PBO0004315, PBO0004580.
Safeguard US Operating LLC is recalling HAWK Advanced Hypothermia Management Set, Item Number: 59-320 due to Incorrect expiration date.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect expiration date.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026