Reported Apr 11, 2018 · Terminated
Arterial Access Tray, introducer catheter; Model: GU-04020
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?
- Arterial Access Tray, introducer catheter
- ModelGU-04020
- Lot codes and dates
- Lots
13F17A029213F17C030913F17E035913F17G030013F17J024223F16F062323F16G0675
- Expiration datesOctober 2018 through March 2020
- Lots
- Amount recalled
- 1190
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.
Want the full recall guide?
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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