Recall Z-3182-2024 ยท IMD Pack, Hot Or Cold, Disposable
Safeguard US Operating LLC
HAWK Advanced Hypothermia Management Set, Item Number: 59-320
| Date | Sep 19, 2024 (initiated Aug 27, 2024) |
| Status | Open, Classified |
| Reason | Incorrect expiration date. |
| 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 notificat |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.