JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules
FDA device recall Z-2637-2025 · posted 2025-09-26 · Open, Classified
Recall details
- Recalling firm
- North American Rescue LLC.
- 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.
- Action taken
- 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 recalls@narescue.com 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
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- DXC
- Quantity affected
- 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
- Date initiated
- 2025-07-01
- Date posted
- 2025-09-26
- Location
- Greer, SC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088 (K123194) | North American Rescue Products, Inc. | 2013-01-03 |