Z-2637-2025Class II

JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training...

Name: Z-2637-2025 JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training...
Creator: North American Rescue LLC.
Published: 2025-07-01
License: https://open.fda.gov/license/

North American Rescue LLC. / initiated 2025-07-01 / Open, Classified / root cause: manufacturing process

FDA source

North American Rescue LLC. began a recall of 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... on 2025-07-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2637-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-01
Posted: 2025-09-26
Recalling firm: North American Rescue LLC.
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
Product code: DXC Clamp, Vascular
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 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 recall should be carried out to the user level. If you have questions contact the firm's customer service at 1-888-689-6277
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2637-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2637-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-09-26

Product code DXC

K123194Class IIJunctional Emergency Treatment Tool Model 30-0088North American Rescue Products, Inc. / cleared 2013-01-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)