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Recall Observatory FDA recall evidence

Device product

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).

Z-3183-2024

August 27, 2024

Class II

Product summary

Firm
Safeguard US Operating LLC
Event
Event 95183
Status
Ongoing
Classification
Class II
Quantity
567 units
Official record key
device-enforcement:Z-3183-2024

Official wording

Reason: Incorrect expiration date.

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.

Distribution pattern: US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, NC, NM, NY, OK, OR, RI, TX, VA, WA, WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect expiration date.