Reported Apr 11, 2018 · Terminated
Radial Artery Catheterization Kit; Model: AK-04020-C
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?
- Radial Artery Catheterization Kit
- ModelAK-04020-C
- Lot codes and dates
- Lots
13F16H043013F16M022413F16M024213F17F015013F17F047513F17G024023F16E119323F16F047623F16G008523F16H001323F16H0680
- Expiration datesOctober 2018 through March 2020
- Lots
- Amount recalled
- 24,192
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
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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