FDA Medical Device Recalls (openFDA)
Safeguard US Operating LLC: HAWK Advanced Hypothermia Management Set, Item Number: 59-320
- Recall number
- Z-3182-2024
- Recalling firm
- Safeguard US Operating LLC
- Product
- HAWK Advanced Hypothermia Management Set, Item Number: 59-320
- Status
- Open, Classified
- Initiated
- 2024-08-27
- Posted
- 2024-09-19
- Terminated
- not on file
- 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 notification.
- 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.
- Lot, serial or model codes
- Item Number: 59-320; Lot Numbers: PBO0003797, PBO0003811, PBO0004032, PBO0004315, PBO0004580.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IMD
- Firm FEI
- 3008258694
- Firm city
- Harrisburg
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28