Reported Apr 2, 2014 · Terminated
5/10/12MM X 100MM Weck¿ Vista" UNIVERSAL CONE OPEN ACCESS, Product Usage: An endoscope and accessories is a device used…
Teleflex Medical
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: Teleflex Medical · 2917 Weck Dr. · Research Triangle Park, NC · 27709
Is this the product you have?
- 5/10/12MM X 100MM Weck¿ Vista" UNIVERSAL CONE OPEN ACCESS
- Product UsageAn endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals
- Lot codes and dates
- Product Code405912R
- Lot Numbers
01H120006401K120037801K120062101L120037001M120007101M120025201A130017001A130020101A130042001A1300545and 01F1300136
- Amount recalled
- 55,521 ea. in total
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
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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