Reported Sep 21, 2016 · Terminated
Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
Arrow International 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: Arrow International Inc · 2400 Bernville Rd · Reading, PA · 19605-9607
Is this the product you have?
- Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
- Lot codes and dates
- Lot/Batch Numbers
23F15L066223F15J026023F15K098323F15G015923F15J110223F15J0259 23F15C122523S15G097323F15H103323F15F035823F15K034523F15D1514 23F15C122623F15H091923F15E109123F15H001423F15D024123F15J0533 23F15E109423F15H002023F15H074023F15K100923F15J043123F15F1836 23F15H085723F15K001223F15M031323F15G087123F15J0285
- Lot/Batch Numbers
- Amount recalled
- 6,121 units in total
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
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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