Class 2 Device Recall 4 Inch Flat Responder Emergency Trauma Dressing

• Date Initiated by Firm: August 21, 2020
• Create Date: September 25, 2020
• Recall Status: Terminated on January 31, 2024
• Recall Number: Z-3018-2020
• Recall Event ID: 86340
• Product Classification: Bandage, elastic - Product Code FQM
• Product: 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
• Code Information: 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
• Recalling Firm/ Manufacturer: North American Rescue LLC.; 35 Tedwall Ct; Greer SC 29650-4791
• For Additional Information Contact: William Slevin; 864-675-9800
• Manufacturer Reason for Recall: Lack of sterility assurance of the 30-0171
• FDA Determined Cause: Under Investigation by firm
• Action: North American Rescue issued an urgent medical device recall notice on August 25,2020. It state the following: This recall is only for 30-0171 NAR Responder 4" Flat Emergency Trauma Dressing. All other components packaged in the first aid kit are not affected by this recall. 1. Examine your inventory and quarantine all product and kits identified in this recall notification. 2. Discontinue all distribution or use of the recalled products identified in the recall notification. 3. Identify the 30-0171 and verify the recalled lot TSD2419 or TS00320. 4. Remove the recalled lot TS02419 or TSD0320 from the kit and quarantine. 5. Contact NAR Customer Service toll free at 1-800-689-6277 to receive credit or replacement and arrange for the return of the recalled lots. (P lease have your customer order number available to reference.) If you have further distributed this product, please Identify your customers and immediately notify them of this product recall. Please complete and return the response form as soon as possible. If you have any questions, call William Slevin at (864) 675-9800. The recall notice is posted on firm's website : www.narescue.com
• Quantity in Commerce: 11404 each
• Distribution: US Nationwide distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.