Reported Apr 9, 2014 · Terminated
5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista…
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 · 4024 Stirrup Creek Dr · Durham, NC · 27703-9000
Is this the product you have?
- 5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Access Port - Long Length (100mm), Catalog No. 410944L; 5/10 Weck Vista Universal Balloon Open Access Port - Short Length (53mm), Catalog No. 410944S; 5/10/12 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 412944; 5/10/12 Weck Vista Universal Balloon Open Access Port - Long Length (100 mm), Catalog No. 412944L. An 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
4 of 4 products
Products covered by this recall Model / number Product as published 410944Lots - 01K1200601, 01K1200623, 01L1200355, 01L1200378, 01A1300203, 01D1300412, 01J1200241, 01K1200066, 01K1200622 410944SCatalog No. 410944L - 01J1200219, 01K1200067, 01K1200600, 01L1200056, 01L1200354, 01A1300202, - 01L1200460, 01K1200619, 01L1200515, 01E1300137 41294401J1200241, 01K1200066, 01K1200622 412944L01J1200231, 01K1200597, 01K1200618, 01K1200728, 01A1300178, 01D1300316, 01E1300310, 01E1300436 - Amount recalled
- 55,521 total
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Complaints of leakage of insufflation gas through the device.
This product could cause temporary or reversible health problems — stop using it.
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