HAWK Warming Grid, Item Number: 59-300
FDA device recall Z-3181-2024 · posted 2024-09-19 · Open, Classified
Recall details
- Recalling firm
- Safeguard US Operating LLC
- Reason for recall
- Incorrect expiration date.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- IMD
- Quantity affected
- 655 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.
- Date initiated
- 2024-08-27
- Date posted
- 2024-09-19
- Location
- Harrisburg, NC
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