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Teleflex Medical recalls 5/10 Weck¿ Vista" Universal Balloon Open Access Port - Standard Length (70mm), Product Usage: An endoscope and ac
Recalled April 2, 2014 · FDA recall Z-1286-2014 · Teleflex Medical
Hazard
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. · FDA Class II
Units
55,521 ea. in total
Sold at
Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.
Description
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
Product
5/10 Weck¿ Vista" Universal Balloon Open Access Port - Standard Length (70mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Manufacturer(s)
Teleflex Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →