🔍 RecallPedia

Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue

Class I - Dangerous
💊 Drugs Recalled: September 27, 2016 North American Rescue Other Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Kit Part # 80-0213 - Kit Lot # 80-0213080816W, 80-0213071316W, 80-0213041816W, 80-0213051716W, 80-0213050516W, 80-0213050916W, 80-0213081116W, 80-0213081716W, 80-0213082516W, 80-0213090216W, 80-0213090916W, 80-0213070716W, 80-0213080316W, 80-0213080116W, 80-0213072716W, 80-0213090916W; Kit Part # 80-0299 - Kit Lot # 80-0299080916W, 80-0299071116W, 80-0299060116W, 80-0299051916W, 80-0299081716W, 80-0299050316W, 80-0299051016W, 80-0299082216W; 80-0299082416W, 80-0299090616W, 80-0299090716W, 80-0299090716W, 80-0299080416W; Kit Part # 80-0298 - Kit Lot # 80-0298081116W, 80-0298060116W, 80-0298062316W, 80-0298090716W
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
North American Rescue LLC.
Reason for Recall:
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue

Product Codes/Lot Numbers:

Kit Part # 80-0213 - Kit Lot # 80-0213080816W, 80-0213071316W, 80-0213041816W, 80-0213051716W, 80-0213050516W, 80-0213050916W, 80-0213081116W, 80-0213081716W, 80-0213082516W, 80-0213090216W, 80-0213090916W, 80-0213070716W, 80-0213080316W, 80-0213080116W, 80-0213072716W, 80-0213090916W; Kit Part # 80-0299 - Kit Lot # 80-0299080916W, 80-0299071116W, 80-0299060116W, 80-0299051916W, 80-0299081716W, 80-0299050316W, 80-0299051016W, 80-0299082216W; 80-0299082416W, 80-0299090616W, 80-0299090716W, 80-0299090716W, 80-0299080416W; Kit Part # 80-0298 - Kit Lot # 80-0298081116W, 80-0298060116W, 80-0298062316W, 80-0298090716W

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0176-2017

Related Recalls

JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK COMBO, REF: 85-0740, KIT, TCCC/TECC MODULE ONE SKILLS REFILL, REF: 85-1900

North American Rescue

Class I - Dangerous

Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.

Jul 1, 2025 Other Medical Devices Nationwide View Details →

4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini First Aid Kit; Kit Product Code: 80-0890 b) M-FAK Mini First Aid Kit, with Bleeding Control Dressing; Kit Product Code: 80-0891 c) M-FAK Mini First Aid Kit, Advance; Kit Product Code: 80-0892 d) M-FAK Mini First Aid Kit, Basic; Kit Product Code: 80-0913 e) M-FAK Mini First Aid Kit; Kit Product Code: 80-0914 f) Trauma and First Aid Kit; Kit Product Code: 80-0947 g) Trauma and First Aid Kit; Kit Product Code: 80-0948 h) Trauma and First Aid Kit; Kit Product Code: 80-1047 i) Trauma and First Aid Kit Hard Case, Class B, with Bleeding Control Dressing; Kit Product Code: 80-1048 j) Micro individual first aid kit; Kit Product Code: 82-0002 k) Individual Aid Kit; Kit Product Code: 85-0404 l) KMBR HII Kit; Kit Product Code: 85-0757 m) Compact Officer Response Emergency Kit; Kit Product Code: 85-0834 n) Public Access Bleeding Control Twin Pack, Basic; Kit Product Code: 80-0951 o) Public Access Bleeding Control Twin Pack, Intermediate; Kit Product Code: 80-0952 p) Public Access Bleeding Control Twin Pack, Advanced BCD; Kit Product Code: 80-0953 q) Trauma and First Aid Kit; Kit Product Code: 80-1033 r) Trauma and First Aid Kit Hard Case; Kit Product Code: 80-1034 s) Tactical Quick Reaction Individual first aid kit; Kit Product Code: 85-1128 t) M-FAK Kit with S-Rolled Gauze; Kit Product Code: 85-1502 u) Public access individual bleeding control kit; Kit Product Code: 85-1574 v) Emergency Trauma Bleeding control pack; Kit Product Code: 85-1583 w) Bleeding control Kit; Kit Product Code: 85-1759 x) TORK Kit; Kit Product Code: 85-1907 y) Black scout survival IFAK individual first aid kit; Kit Product Code: 85-1942 z) Texas water first aid kit; Kit Product Code: 85-1953 aa) Crisis Ki; Kit Product Code: 85-1970 ab) ALE IFAK individual first aid kit; Kit Product Code: 85-2150 ac) RACH regional advisory council hemorrhage kit; Kit Product Code: 85-2176 ad) Triad Medical's SRAK student response aid kit; Kit Product Code: 85-2327 ae) ODIN medical EMT kit; Kit Product Code: 85-2425 af) ODIN medical AEMT kit; Kit Product Code: 85-2426 ag) Henry Schein public access individual bleeding control kit; Kit Product Code: 85-2430 ah) Henry Schein public access individual bleeding control kit; Kit Product Code: 85-2432 ai) Warrior Poet society Public access individual bleeding control kit; Kit Product Code: 85-2539 aj) Spec Train Compact Carry kit; Kit Product Code: 85-2833 ak) Belfast FD resupply kit; Kit Product Code: 85-2886 al) Trauma and First Aid Kit; Kit Product Code: 80-1045 am) Trauma and First Aid Kit Hard Case Class A, with Bleeding Control Dressing; Kit Product Code: 80-1046 an) M-FAK Kit; Kit Product Code: 85-2920 ao) IFAK individual first aid kit; Kit Product Code: 85-3022 ap) Bleeding control kit; Kit Product Code: 85-3046 aq) Individual first aid kit allegiance holster company; Kit Product Code: 85-3050 ar) RAC-PAK; Kit Product Code: 85-3052 as) Bleeding control E.F.A.K enhanced first aid kit; Kit Product Code: 85-3067 at) Bleeding control E.F.A.K enhanced first aid kit; Kit Product Code: 85-3068 au) Bleeding control E.F.A.K enhanced first aid kit; Kit Product Code: 85-3069 av) Task Force 6 resupply kit; Kit Product Code: 85-3078 aw) PABC Kit; Kit Product Code: 85-3082 ax) MCC IFAK Small Supply Kit; Kit Product Code: 85-3084 ay) MCC IFAK Large Supply Kit; Kit Product Code: 85-3085

North American Rescue

Class I - Dangerous

Lack of sterility assurance of the 30-0171

Aug 21, 2020 Infusion Pumps Nationwide View Details →