4 In — Class II medical device recall Z-3018-2020
Terminated recall by North American Rescue LLC., reported 2020-10-07, distributed nationwide. Lack of sterility assurance of the 30-0171
| Recall number | Z-3018-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | North American Rescue LLC., Greer, SC, United States |
| Recall initiated | 2020-08-21 |
| Classified | 2020-09-25 |
| Reported by FDA | 2020-10-07 |
| Terminated | 2024-01-31 |
| Distributed | Nationwide (US) |
| Quantity | 11,404 units |
| Reason classes | sterility |
| Lot numbers | 80-0890032420, 80-0891032520, 80-0891032620, 80-0891032720, 80-0891040620, 80-0891042020, 80-0891050420, 80-0891050620, 80-0891051120, 80-0891051920, 80-0891052120, 80-0891052220, 80-0891072920, 80-0892042720, 80-0892052020, 80-0913031320, 80-0913032020, 80-0913032420, 80-0913032620, 80-0913042120, 80-0913042820, 80-0913050620, 80-0913051120, 80-0913072920, 80-0914041520, 80-0914072920, 80-0947031720, 80-0947032420, 80-0947032720, 80-0947033120, 80-0947040220, 80-0947040620, 80-0947041720, 80-0947042320, 80-0947052820, 80-0947072720, 80-0948031620, 80-0948032020, 80-0948032420, 80-0948032620 and 144 more |
| Model numbers | 30-0171 |
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
Reason for recall
Lack of sterility assurance of the 30-0171
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3018-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.