North American Rescue LLC.
FDA Regulatory Profile
Summary
- Total Recalls
- 12
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2637-2025 | Class II | JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Tra | July 1, 2025 |
| Z-2520-2021 | Class II | 10 ga ARS Decompression Needle, Part Number ZZ-0298 | August 27, 2021 |
| Z-3018-2020 | Class II | 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as foll | August 21, 2020 |
| D-0182-2017 | Class II | Aid Backpack Kit - Product Code 85-0917, North American Rescue | September 27, 2016 |
| D-0175-2017 | Class II | Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue | September 27, 2016 |
| D-0183-2017 | Class II | USCG Boat Response Kit - Product Code 80-0353, North American Rescue | September 27, 2016 |
| D-0176-2017 | Class II | Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue | September 27, 2016 |
| D-0178-2017 | Class II | Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, Nor | September 27, 2016 |
| D-0177-2017 | Class II | Range Trauma Kit - Product Code 85-1274, North American Rescue | September 27, 2016 |
| D-0181-2017 | Class II | Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue | September 27, 2016 |
| D-0180-2017 | Class II | Amphibious Trauma Kit - Product Code 85-0639, North American Rescue | September 27, 2016 |
| D-0179-2017 | Class II | K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North Amer | September 27, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K152340 | NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six | May 31, 2016 |