FDA Recall Open, Classified

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

Recall: Z-3182-2024 · Initiated August 27, 2024

Recall

Recall Number
Z-3182-2024
Event Number
95183
Firm
Safeguard US Operating LLC
FEI Number
3008258694
Product Code
IMD
Status
Open, Classified
Root Cause
Process control
Initiated
August 27, 2024
Posted
September 19, 2024
Address
5555 Harrisburg Ind Pk Dr, Harrisburg, NC, 28075-7407

Description

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

Reason

Incorrect expiration date.

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.

Distribution

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

Quantity

408 units