Reported Jun 6, 2018 · Terminated
Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418
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?
- Spring Wire Guide Introducer Needle
- Product CodesAN-04320 and AN-04418
- Lot codes and dates
- Lot NumbersProduct
- code AN-04320
13F17A013113F17B010113F17B032013F17D023413F17F024213F17H048813F17J045413F17M0003
- Product code AN-0441813F17F0738 and 13F17J0445
- Amount recalled
- 416,055 total products
This recall covers 76 products
The agency filed one notice per product. You are reading one of them; the other 75 are below.
63 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
Product sterility may be compromised due to unsealed packaging.
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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