| | Class 2 Device Recall JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT) |  |
| Date Initiated by Firm | July 01, 2025 |
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| Date Posted | September 26, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2637-2025 |
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| Recall Event ID |
97308 |
| 510(K)Number | K123194 |
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| Product Classification |
Clamp, vascular - Product Code DXC
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| 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 |
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| 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
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Recalling Firm/
Manufacturer |
North American Rescue LLC.
35 Tedwall Ct
Greer SC 29650-4791
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| For Additional Information Contact |
864-675-9800 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Nonconforming Material/Component |
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| 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 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 |
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| Quantity in Commerce | 552 |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = DXC
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