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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot numbers: TSD3819 and TSD0320, packaged in kits with the following Kit Product Codes and Kit Lot Numbers: a) Kit Product Code: 80-0890; Kit Lot Number :80-0890032420 b) Kit Product Code: 80-0891; Kit Lot Number: 80-0891032520, 80-0891032620 80-0891032720, 80-0891040620, 80-0891042020, 80-0891050420, 80-0891050620, 80-0891051120, 80-0891051920, 80-0891052120, 80-0891052220, 80-0891072920 c) Kit Product Code: 80-0892, Kit Lot Number: 80-0892042720, 80-0892052020 d) Kit Product Code: 80-0913, Kit Lot Number: 80-0913031320, 80-0913032020 80-0913032420, 80-0913032620, 80-0913042120, 80-0913042820, 80-0913050620, 80-0913051120, 80-0913072920 e) Kit Product Code: 80-0914, Kit Lot Number: 80-0914041520, 80-0914072920 f) Kit Product Code: 80-0947, Kit Lot Number: 80-0947031720, 80-0947032420, 80-0947032720, 80-0947033120, 80-0947040220, 80-0947040620, 80-0947041720, 80-0947042320, 80-0947052820, 80-0947072720 g) Kit Product Code: 80-0948, Kit Lot Number: 80-0948031620, 80-0948032020 80-0948032420, 80-0948032620, 80-0948033020, 80-0948033120, 80-0948040720, 80-0948041720, 80-0948042320, 80-0948072320 h) Kit Product Code: 80-1047, Kit Lot Number: 80-1047031720, 80-1047032120, 80-1047032420, 80-1047040720, 80-1047060420, 80-1047072220,80-1047072920 i) Kit Product Code: 80-1048, Kit Lot Number: 80-1048032720, 80-1048052020, 80-1048073020 j) Kit Product Code: 82-0002, Kit Lot Number: 82-0002031620, 82-0002031820, 82-0002032020, 82-0002033020, 82-0002040720, 82-0002042320, 82-0002042720, 82-0002042820, 82-0002051320, 82-0002072420, 82-0002072820 k) Kit Product Code: 85-0404, Kit Lot Number: 85-0404032320, 85-0404032520, 85-0404050720, 85-0404050820, 85-0404051120, 85-0404051220, 85-0404052220, 85-0404052620, 85-0404052720, 85-0404072320 l) Kit Product Code: 85-0757, Kit Lot Number: 85-0757050420, 85-0757050520 m) Kit Product Code: 85-0834, Kit Lot Number: 85-0834051120, 85-0834051220, 85-0834051420, 85-0834051520, 85-0834051820, 85-0834051920, 85-0834052120, 85-0834052620 n) Kit Product Code: 80-0951, Kit Lot Number: 80-0951031820, 80-0951032320 80-0951032420, 80-0951032620, 80-0951042020, 80-0951042220, 80-0951042820, 80-0951042920, 80-0951050420, 80-0951051120, 80-0951051520, 80-0951052020 o) Kit Product Code: 80-0952, Kit Lot Number: 80-0952040220, 80-0952042020, 80-0952042920, 80-0952051820, 80-0952052220 p) Kit Product Code: 80-0953, Kit Lot Number: 80-0953050420, 80-0953051220 80-0953051820, 80-0953072220 q) Kit Product Code: 80-1033, Kit Lot Number: 80-1033032320, 80-1033032420 80-1033040220, 80-1033040320, 80-1033051820, 80-1033052020, 80-1033052120 r) Kit Product Code: 80-1034, Kit Lot Number: 80-1034031320, 80-1034031720 80-1034031920, 80-1034040720, 80-1034042120, 80-1034042220, 80-1034052020, 80-1034052120, 80-1034072820 s) Kit Product Code: 85-1128, Kit Lot Number: 85-1128031820, 85-1128031920 t) Kit Product Code: 85-1502, Kit Lot Number: 85-1502040620 u) Kit Product Code: 85-1574, Kit Lot Number: 85-1574031320, 85-1574031620 85-1574032520, 85-1574032620, 85-1574050520, 85-1574050620, 85-1574050720, 85-1574050820, 85-1574051220 v) Kit Product Code: 85-1583, Kit Lot Number: 85-1583040320, 85-1583042420 w) Kit Product Code: 85-1759, Kit Lot Number: 85-1759031320 x) Kit Product Code: 85-1907, Kit Lot Number: 85-1907033020, 85-1907033120 y) Kit Product Code: 85-1942, Kit Lot Number: 85-1942032020, 85-1942040820, 85-1942042120, 85-1942052020 z) Kit Product Code: 85-1953, Kit Lot Number: 85-1953043020 aa) Kit Product Code: 85-1970, Kit Lot Number: 85-1970040220 ab) Kit Product Code: 85-2150, Kit Lot Number: 85-2150032620 ac) Kit Product Code: 85-2176, Kit Lot Number: 85-2176031620 ad) Kit Product Code: 85-2327, Kit Lot Number: 85-2327040720 ae) Kit Product Code: 85-2425, Kit Lot Number: 85-2425072920 af) Kit Product Code: 85-2426, Kit Lot Number: 85-2426072920 ag) Kit Product Code: 85-2430 Kit Lot Number: 85-2430031820 ah) Kit Product Code: 85-2432 Kit Lot Number: 85-2432042920 ai) Kit Product Code: 85-2539; Kit Lot Number: 85-2539042920, 85-2539051220, 85-2539052820, 85-2539072320 aj) Kit Product Code: 85-2833; Kit Lot Number: 85-2833043020 ak) Kit Product Code: 85-2886; Kit Lot Number: 85-2886032420 al) Kit Product Code: 80-1045; Kit Lot Number: 80-1045031820, 80-1045032620 80-1045033120, 80-1045052620, 80-1045072720 am) Kit Product Code: 80-1046; Kit Lot Number: 80-1046032420, 80-1046042320, 80-1046042720 an) Kit Product Code: 85-2920; Kit Lot Number: 85-2920032420, 85-2920040120 ao) Kit Product Code: 85-3022; Kit Lot Number: 85-3022031820 ap) Kit Product Code: 85-3046; Kit Lot Number: 85-3046051320 aq) Kit Product Code: 85-3050; Kit Lot Number: 85-3050040220 ar) Kit Product Code: 85-3052; Kit Lot Number: 85-3052042120, 85-3052051820 as) Kit Product Code: 85-3067; Kit Lot Number: 85-3067042820 at) Kit Product Code: 85-3068; Kit Lot Number: 85-3068042920 au) Kit Product Code: 85-3069; Kit Lot Number: 85-3069042920 av) Kit Product Code: 85-3078; Kit Lot Number: 85-3078050620 aw) Kit Product Code: 85-3082; Kit Lot Number: 85-3082050620 ax) Kit Product Code: 85-3084; Kit Lot Number: 85-3084052020 ay) Kit Product Code: 85-3085; Kit Lot Number: 85-3085052020
  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 sterility assurance of the 30-0171
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lot numbers: TSD3819 and TSD0320, packaged in kits with the following Kit Product Codes and Kit Lot Numbers: a) Kit Product Code: 80-0890; Kit Lot Number :80-0890032420 b) Kit Product Code: 80-0891; Kit Lot Number: 80-0891032520, 80-0891032620 80-0891032720, 80-0891040620, 80-0891042020, 80-0891050420, 80-0891050620, 80-0891051120, 80-0891051920, 80-0891052120, 80-0891052220, 80-0891072920 c) Kit Product Code: 80-0892, Kit Lot Number: 80-0892042720, 80-0892052020 d) Kit Product Code: 80-0913, Kit Lot Number: 80-0913031320, 80-0913032020 80-0913032420, 80-0913032620, 80-0913042120, 80-0913042820, 80-0913050620, 80-0913051120, 80-0913072920 e) Kit Product Code: 80-0914, Kit Lot Number: 80-0914041520, 80-0914072920 f) Kit Product Code: 80-0947, Kit Lot Number: 80-0947031720, 80-0947032420, 80-0947032720, 80-0947033120, 80-0947040220, 80-0947040620, 80-0947041720, 80-0947042320, 80-0947052820, 80-0947072720 g) Kit Product Code: 80-0948, Kit Lot Number: 80-0948031620, 80-0948032020 80-0948032420, 80-0948032620, 80-0948033020, 80-0948033120, 80-0948040720, 80-0948041720, 80-0948042320, 80-0948072320 h) Kit Product Code: 80-1047, Kit Lot Number: 80-1047031720, 80-1047032120, 80-1047032420, 80-1047040720, 80-1047060420, 80-1047072220,80-1047072920 i) Kit Product Code: 80-1048, Kit Lot Number: 80-1048032720, 80-1048052020, 80-1048073020 j) Kit Product Code: 82-0002, Kit Lot Number: 82-0002031620, 82-0002031820, 82-0002032020, 82-0002033020, 82-0002040720, 82-0002042320, 82-0002042720, 82-0002042820, 82-0002051320, 82-0002072420, 82-0002072820 k) Kit Product Code: 85-0404, Kit Lot Number: 85-0404032320, 85-0404032520, 85-0404050720, 85-0404050820, 85-0404051120, 85-0404051220, 85-0404052220, 85-0404052620, 85-0404052720, 85-0404072320 l) Kit Product Code: 85-0757, Kit Lot Number: 85-0757050420, 85-0757050520 m) Kit Product Code: 85-0834, Kit Lot Number: 85-0834051120, 85-0834051220, 85-0834051420, 85-0834051520, 85-0834051820, 85-0834051920, 85-0834052120, 85-0834052620 n) Kit Product Code: 80-0951, Kit Lot Number: 80-0951031820, 80-0951032320 80-0951032420, 80-0951032620, 80-0951042020, 80-0951042220, 80-0951042820, 80-0951042920, 80-0951050420, 80-0951051120, 80-0951051520, 80-0951052020 o) Kit Product Code: 80-0952, Kit Lot Number: 80-0952040220, 80-0952042020, 80-0952042920, 80-0952051820, 80-0952052220 p) Kit Product Code: 80-0953, Kit Lot Number: 80-0953050420, 80-0953051220 80-0953051820, 80-0953072220 q) Kit Product Code: 80-1033, Kit Lot Number: 80-1033032320, 80-1033032420 80-1033040220, 80-1033040320, 80-1033051820, 80-1033052020, 80-1033052120 r) Kit Product Code: 80-1034, Kit Lot Number: 80-1034031320, 80-1034031720 80-1034031920, 80-1034040720, 80-1034042120, 80-1034042220, 80-1034052020, 80-1034052120, 80-1034072820 s) Kit Product Code: 85-1128, Kit Lot Number: 85-1128031820, 85-1128031920 t) Kit Product Code: 85-1502, Kit Lot Number: 85-1502040620 u) Kit Product Code: 85-1574, Kit Lot Number: 85-1574031320, 85-1574031620 85-1574032520, 85-1574032620, 85-1574050520, 85-1574050620, 85-1574050720, 85-1574050820, 85-1574051220 v) Kit Product Code: 85-1583, Kit Lot Number: 85-1583040320, 85-1583042420 w) Kit Product Code: 85-1759, Kit Lot Number: 85-1759031320 x) Kit Product Code: 85-1907, Kit Lot Number: 85-1907033020, 85-1907033120 y) Kit Product Code: 85-1942, Kit Lot Number: 85-1942032020, 85-1942040820, 85-1942042120, 85-1942052020 z) Kit Product Code: 85-1953, Kit Lot Number: 85-1953043020 aa) Kit Product Code: 85-1970, Kit Lot Number: 85-1970040220 ab) Kit Product Code: 85-2150, Kit Lot Number: 85-2150032620 ac) Kit Product Code: 85-2176, Kit Lot Number: 85-2176031620 ad) Kit Product Code: 85-2327, Kit Lot Number: 85-2327040720 ae) Kit Product Code: 85-2425, Kit Lot Number: 85-2425072920 af) Kit Product Code: 85-2426, Kit Lot Number: 85-2426072920 ag) Kit Product Code: 85-2430 Kit Lot Number: 85-2430031820 ah) Kit Product Code: 85-2432 Kit Lot Number: 85-2432042920 ai) Kit Product Code: 85-2539; Kit Lot Number: 85-2539042920, 85-2539051220, 85-2539052820, 85-2539072320 aj) Kit Product Code: 85-2833; Kit Lot Number: 85-2833043020 ak) Kit Product Code: 85-2886; Kit Lot Number: 85-2886032420 al) Kit Product Code: 80-1045; Kit Lot Number: 80-1045031820, 80-1045032620 80-1045033120, 80-1045052620, 80-1045072720 am) Kit Product Code: 80-1046; Kit Lot Number: 80-1046032420, 80-1046042320, 80-1046042720 an) Kit Product Code: 85-2920; Kit Lot Number: 85-2920032420, 85-2920040120 ao) Kit Product Code: 85-3022; Kit Lot Number: 85-3022031820 ap) Kit Product Code: 85-3046; Kit Lot Number: 85-3046051320 aq) Kit Product Code: 85-3050; Kit Lot Number: 85-3050040220 ar) Kit Product Code: 85-3052; Kit Lot Number: 85-3052042120, 85-3052051820 as) Kit Product Code: 85-3067; Kit Lot Number: 85-3067042820 at) Kit Product Code: 85-3068; Kit Lot Number: 85-3068042920 au) Kit Product Code: 85-3069; Kit Lot Number: 85-3069042920 av) Kit Product Code: 85-3078; Kit Lot Number: 85-3078050620 aw) Kit Product Code: 85-3082; Kit Lot Number: 85-3082050620 ax) Kit Product Code: 85-3084; Kit Lot Number: 85-3084052020 ay) Kit Product Code: 85-3085; Kit Lot Number: 85-3085052020

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-3018-2020

Related Recalls

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 →