Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Gr...
FDA Recall #Z-3183-2024 — Class II — August 27, 2024
Product Description
Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 59-320 HAWK Advanced Hypothermia Management Set. Convenience kits labeled as follows: Combat Life Saver - Intermediate (Product Number: 83-323-CB) contains 59-300 / 1 Each; Medic Enhancement Resupply (Product Number: 82-504-05) contains 59-300 / 1 Each; Combat Life Saver - Advanced (Product Number: 83-325-CB) contains 59-300 / 1 Each; Cold Weather (Product Number: 82-505) contains 59-300 / 1 Each; HAWK w/ Carrier Set, Multicam, Stocked (Product Number: 83-315-01-MC) contains 59-300 / 1 Each; Mojo Combat Life Saver - Intermediate - Multicam (Product Number: 83-323-MC); Combat Life Saver - Intermediate - Multicam (Product Number: 83-323-MC); Mojo Combat Life Saver - Advanced - Multicam (Product Number: 83-325-MC); DIRECT ACTION BAG, FOLIAGE GREEN, ADVANCED, STOCKED (Product Number: 84-497-FG).
Reason for Recall
Incorrect expiration date.
Recalling Firm
Safeguard US Operating LLC — Harrisburg, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
567 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.
Code Information
1. Product Number: 83-323-CB; Lot Numbers: PBO0004044, PBO0003913, PBO0004523. 2. Product Number: 82-504-05; Lot Numbers: PBO0004123. 3. Product Number: 83-325-CB; Lot Number: PBO0004172. 4. Product Number: 82-505; Lot Number: pbo0003673. 5. Product Number: 83-315-01-MC; Lot Number: PBO0004179. 6. Product Number: 83-323-MC; Lot Number: PBO0004291, PBO0004454. 7. Product Number: 83-325-MC; Lot Number: PBO0004285. 8. Product Number: 84-497-FG; Lot Number: PBO0004817.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated