HAWK Advanced Hypothermia Management Set recalled for incorrect expiration dates
Safeguard US Operating LLC is recalling the HAWK Advanced Hypothermia Management Set due to incorrect expiration dates on affected units. The product may not perform reliably if used after the incorrect date.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a medical device with an incorrect expiration date. While no illnesses or injuries have been reported, incorrect expiration dating on a hypothermia management device presents a risk-of-harm scenario where the product may no longer be reliable if used beyond its actual expiration.
Plain-English summary
Safeguard US Operating LLC is recalling the HAWK Advanced Hypothermia Management Set, Item Number 59-320, due to incorrect expiration dates printed on the packaging. Approximately 408 units are affected by this recall.
An incorrect expiration date on a medical device creates a risk that the device may be used when its actual expiration has passed and the device may no longer function as intended. The affected units distributed nationwide include lot numbers PBO0003797, PBO0003811, PBO0004032, PBO0004315, and PBO0004580.
The recalled units were distributed across multiple states, including Alaska, California, Colorado, the District of Columbia, Georgia, Illinois, North Carolina, New Mexico, New York, Oklahoma, Oregon, Rhode Island, Texas, Virginia, Washington, and Wisconsin.
The recalled product
- Product
- HAWK Advanced Hypothermia Management Set, Item Number: 59-320
- Manufacturer
- Safeguard US Operating LLC
- Affected units
- 408
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Item Number: 59-320
- Lot Numbers: PBO0003797
- PBO0003811
- PBO0004032
- PBO0004315
- PBO0004580.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Safeguard US Operating LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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