Reported Oct 1, 2014 · Terminated
UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and…
Argon Medical Devices, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Argon Medical Devices, Inc · 1445 Flat Creek Rd · Athens, TX · 75751-5002
Is this the product you have?
- UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures.
- Lot codes and dates
- Lot Numbers
1102994911031335110335331103516111036607110378171103971911040058110423051104409211046743110480761104906611056427110594611102410911025359110273761102849011029950110313361103414111036893110377421103855111039237110395241103986411042306110443371104807711048786110500381105447811057548110577631105946411028491110328281103434311038165110402631104255511043587110443821104735811048923110502891105488911059622110658271103577211037651110409431105962411035771110419931105045411059467
- Lot Numbers
- Amount recalled
- 3,783 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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