Recall record at a glance
| Official record | Z-3018-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | North American Rescue LLC. |
| Report date | Oct 7, 2020 |
| Recall initiation date | Aug 21, 2020 |
| Quantity | 11404 each |
| Location | Greer, SC, United States |
Official product 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
Why the product was recalled
Lack of sterility assurance of the 30-0171
Distribution information
US Nationwide distribution
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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