FDA Enforcement
Class II
Ongoing
HAWK Advanced Hypothermia Management Set, Item Number: 59-320
Recall: Z-3182-2024
·
Reported September 25, 2024
Enforcement
- Recall Number
- Z-3182-2024
- Event ID
- 95183
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Safeguard US Operating LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 25, 2024
- Initiation Date
- August 27, 2024
- Classification Date
- September 19, 2024
- Address
- 5555 Harrisburg Ind Pk Dr, Harrisburg, NC, 28075-7407, United States
Description
HAWK Advanced Hypothermia Management Set, Item Number: 59-320
Reason
Incorrect expiration date.
Code Info
Item Number: 59-320; Lot Numbers: PBO0003797, PBO0003811, PBO0004032, PBO0004315, PBO0004580.
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