FDA recall Z-2637-2025

North American Rescue LLC. · Class II · device

Product

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

Reason for recall

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.

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.

Key facts

Status
Ongoing
Initiation date
2025-07-01
Report date
2025-10-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Greer, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2637-2025