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U.S. Department of Health and Human Services

Class 2 Device Recall 4 Inch Flat Responder Emergency Trauma Dressing

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 Class 2 Device Recall 4 Inch Flat Responder Emergency Trauma Dressingsee related information
Date Initiated by FirmAugust 21, 2020
Create DateSeptember 25, 2020
Recall Status1 Terminated 3 on January 31, 2024
Recall NumberZ-3018-2020
Recall Event ID 86340
Product Classification Bandage, elastic - Product Code FQM
Product4 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 ContactWilliam Slevin
864-675-9800
Manufacturer Reason
for Recall
Lack of sterility assurance of the 30-0171
FDA Determined
Cause 2
Under Investigation by firm
ActionNorth 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 Commerce11404 each
DistributionUS Nationwide distribution
Total Product Life CycleTPLC 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.
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