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
Z-2637-2025
Product summary
- Event
- Event 97308
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 552
- Official record key
device-enforcement:Z-2637-2025
Official wording
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.
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
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.
Derived failure modes
-
Manufacturing or process control
manufacturing defect