FDA Device

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

Hazard

Lack of sterility assurance of the 30-0171

What You Should Do

Remedy

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

Products

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 Blee
Brand
North American Rescue LLC.
UPC
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

Units Affected

11404 each