4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as f...
FDA Device Recall #Z-3018-2020 — Class II — August 21, 2020
Recall Summary
| Recall Number | Z-3018-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 21, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | North American Rescue LLC. |
| Location | Greer, SC |
| Product Type | Devices |
| Quantity | 11404 each |
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
Reason for Recall
Lack of sterility assurance of the 30-0171
Distribution Pattern
US Nationwide distribution
Lot / 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
Other Recalls from North American Rescue LLC.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2637-2025 | Class II | JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF... | Jul 1, 2025 |
| Z-2520-2021 | Class II | 10 ga ARS Decompression Needle, Part Number ZZ-... | Aug 27, 2021 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.