Z-2637-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 8, 2025
- Initiation Date
- July 1, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 552
Product Description
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 Pattern
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.
Code Information
JETT: REF: 30-0088 UDIs: (01)00842209100002(11)240426(10)0212241, (01)00842209100002(11)240515(10)817221, (01)00842209100002(11)240530(10)817222, (01)00842209100002(11)240618(10)817222, (01)00842209100002(11)240701(10)817222, (01)00842209100002(11)240712(10)1213231. REF: 30-0088: Lots: 021224-1, 81722-1, 81722-2, 121323-1. Kits: REF/UDI-DI/Lot: 85-0550/00842209110711/85-0550091824, 85-0550090424, 85-0550030725, 85-0550052925, 85-0550052325, 85-0550082324, 85-0550080624, 85-0550062624, 85-0550052124, 85-0550111424, 85-0550102924; 85-0519/00842209110742/85-0519090324, 85-0519081924; 85-2420/00842209113910/85-2420041725, 85-2420042125, 85-2420100324; 85-0740/00842209110599/85-0740042925, 85-0740050625, 85-0740052925, 85-0740081224, 85-0740082924, 85-0740011325, 85-0740122324, 85-0740121724, 85-0740112024, 85-0740110424, 85-0740102524; 85-1900/00842209110810/85-1900082124, 85-1900031125