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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

Safeguard US Operating LLC: HAWK Warming Grids and Hypothermia Sets Recalled for Incorrect Expiration Dates

Agency Publication Date: September 19, 2024
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Summary

Safeguard US Operating LLC is recalling 1,630 units of HAWK Warming Grids, Hypothermia Management Sets, and various medical convenience kits because they were labeled with incorrect expiration dates. These devices are used to manage patient body temperature in emergency or clinical settings, and an incorrect date could lead to the use of components beyond their intended shelf life. The recall affects specific HAWK products and multi-item kits like the Combat Life Saver and Cold Weather resupply sets sold across 16 U.S. states.

Risk

The use of medical devices past their actual expiration date may result in decreased performance or compromised sterility of the components, potentially leading to ineffective treatment for hypothermia or an increased risk of infection for the patient. No injuries or incidents have been reported to date.

What You Should Do

  1. Check your medical supplies for HAWK Warming Grids (Item 59-300), HAWK Advanced Hypothermia Management Sets (Item 59-320), or various 'Kits of Convenience' such as Combat Life Saver or Cold Weather kits.
  2. Verify your lot numbers against the affected list. For Warming Grids (59-300), look for lot numbers PBO0003427, PBO0004028, PBO0004222, PBO0004293, and PBO0004627. For Hypothermia Management Sets (59-320), look for lot numbers PBO0003797, PBO0003811, PBO0004032, PBO0004315, and PBO0004580.
  3. If you possess convenience kits, check for Product Numbers 83-323-CB, 82-504-05, 83-325-CB, 82-505, 83-315-01-MC, 83-323-MC, 83-325-MC, or 84-497-FG with lot numbers starting with 'PBO'.
  4. Contact your healthcare provider or Safeguard US Operating LLC at their Harrisburg, NC facility for further instructions and information regarding a potential refund or replacement of the mislabeled items.
  5. For additional questions or to report issues, contact the FDA directly at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Contact for guidance on mislabeled products.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: HAWK Warming Grid
Model / REF:
59-300
Lot Numbers:
PBO0003427
PBO0004028
PBO0004222
PBO0004293
PBO0004627
Product: HAWK Advanced Hypothermia Management Set
Model / REF:
59-320
Lot Numbers:
PBO0003797
PBO0003811
PBO0004032
PBO0004315
PBO0004580
Product: Combat Life Saver - Intermediate
Model / REF:
83-323-CB
Lot Numbers:
PBO0004044
PBO0003913
PBO0004523
Product: Medic Enhancement Resupply
Model / REF:
82-504-05
Lot Numbers:
PBO0004123
Product: Combat Life Saver - Advanced
Model / REF:
83-325-CB
Lot Numbers:
PBO0004172
Product: Cold Weather Kit
Model / REF:
82-505
Lot Numbers:
pbo0003673
Product: HAWK w/ Carrier Set, Multicam, Stocked
Model / REF:
83-315-01-MC
Lot Numbers:
PBO0004179
Product: Mojo Combat Life Saver - Intermediate - Multicam
Model / REF:
83-323-MC
Lot Numbers:
PBO0004291
PBO0004454
Product: Mojo Combat Life Saver - Advanced - Multicam
Model / REF:
83-325-MC
Lot Numbers:
PBO0004285
Product: DIRECT ACTION BAG, FOLIAGE GREEN, ADVANCED, STOCKED
Model / REF:
84-497-FG
Lot Numbers:
PBO0004817

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95183
Status: Active
Manufacturer: Safeguard US Operating LLC
Sold By: Safeguard US Operating LLC
Manufactured In: United States
Units Affected: 3 products (655 units; 408 units; 567 units)
Distributed To: Alaska, California, Colorado, District of Columbia, Georgia, Illinois, North Carolina, New Mexico, New York, Oklahoma, Oregon, Rhode Island, Texas, Virginia, Washington, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.