Recall Z-2637-2025 ยท DXC Clamp, Vascular
North American Rescue LLC.
JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK COMBO, REF: 85-0740, KIT, TCCC/TECC MODULE ONE SKILLS REFILL, REF: 85-1900
| Date | Sep 26, 2025 (initiated Jul 1, 2025) |
| Status | Open, Classified |
| Reason | Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use. |
| Root cause | Nonconforming Material/Component |
| Action | On 7/1/2025, recall notices were emailed to customers who were asked to do the following: 1) Quarantine the junctional emergency treatment tools. 2) Discontinue use and distribution. 3) Complete and return the response form via email to recalls@narescue.com In addition, if you have further distributed affected products, identify your customers and notify them of this recall. Your notification to your customers may be enhanced by including a copy of the recall notice. Instruct your customers to return affected product to you and then you will coordinate return with the recalling firm. This rec |
| Quantity | 552 |
| Distribution | Worldwide - US Nationwide distribution in the states of SC, OK, ID, KY, VA, NV, IL, TX, CA, FL, LA, NY, LA, ME, PA, AR, AZ, AL, DE, MA, MS, HI, WA, MI, GA, NJ, UT, MD, OR, NC, NC, AL and the countries of KOR, JPN, BWA, SAU, BEL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123194 | JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088 North American Rescue Products, Inc., Jan 3, 2013 |