Junctional tourniquet devices recalled over manufacturing defect affecting structural integrity
North American Rescue is recalling 552 Junctional Emergency Treatment Tools over a potential manufacturing defect that may compromise structural integrity and performance during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a defect that may compromise a haemorrhage control device during use is a risk of harm, and no injuries are reported.
Plain-English summary
The Junctional Emergency Treatment Tool (JETT), REF 30-0088, is being recalled, both as a standalone device and as a component inside training and response kits including KIT TCCC Training-Complete Modules 1-3 (REF 85-0550), KIT TCCC Module One-Skills (REF 85-0519) and KIT Multi Mission Expeditionary Response (MMERK).
The device is used for unilateral or bilateral occlusion of blood flow to the lower limbs. It has a potential manufacturing defect that may compromise the structural integrity of the device and its performance during use.
The recall covers 552 units, distributed worldwide including in South Carolina, Oklahoma, Idaho, Kentucky, Virginia, Nevada, Illinois, Texas, California, Florida, Louisiana, New York and Maine. The FDA has classified the action as Class II.
Units and kits matching the listed UDIs should be identified and handled per the firm's instructions, and an alternative haemorrhage control device kept available where these are stocked.
The recalled product
- 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…
- Manufacturer
- North American Rescue LLC.
- Affected units
- 552
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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