CLASS II ONGOING Device recall · Reported 25 Sep 2024 · FDA Enforcement Report

Kits of Convenience containing 1 recalled by Safeguard US Operating

Safeguard US Operating is recalling Kits of Convenience containing 1 of the 2, distributed nationwide in the US. The recall was initiated on 27 Aug 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. 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.

Quantity recalled567 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3183-2024
FDA event ID: 95183
Recalling firm: Safeguard US Operating, Harrisburg, NC
Classification: Class II
Status: Ongoing
Recall initiated: 27 Aug 2024
FDA classified: 19 Sep 2024
Reported: 25 Sep 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

27 Aug 2024	Recall initiated by company
19 Sep 2024	Classified by FDA	+23 days
25 Sep 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect expiration date.

Product as listed by the FDA

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).

Where it was distributed

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

Nationwide Alaska California Colorado District of Columbia Georgia Illinois North Carolina New Mexico New York Oklahoma Oregon Rhode Island Texas Virginia Washington Wisconsin

Questions about this recall

Is Kits of Convenience containing 1 of the 2 recalled?

Yes. Safeguard US Operating recalled Kits of Convenience containing 1 of the 2 on 27 Aug 2024. The recall is Class II and its status is Ongoing. Recall number Z-3183-2024.

Why was it recalled?

Incorrect expiration date.

Which lots are affected?

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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Safeguard US Operating

All 3

Reported	Class	Recall	Company	Reason	Where
25 Sep 2024Device	CLASS II	HAWK Warming Grid recalled by Safeguard US Operating	Safeguard US Operating	Other	Nationwide
25 Sep 2024Device	CLASS II	HAWK Advanced Hypothermia Management Set recalled	Safeguard US Operating	Other	Nationwide

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