Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-3182-2024 · Posted 2024-09-19

Recalling FirmSafeguard US Operating LLC
Recall StatusOpen, Classified
Product CodeIMD
Date Initiated2024-08-27
Product Quantity408 units

Reason for Recall

Incorrect expiration date.

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, NC, NM, NY, OK, OR, RI, TX, VA, WA, WI.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑