Reported Jul 19, 2017 · Terminated
Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
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?
- Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
- Lot codes and dates
- Device Listing # D184260 Material # PL-01055
- Amount recalled
- 9,037 units in the U.S. and 4,505 Internationally
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter.
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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