FDA-Device2014-04-02Class II
Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm, 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.
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.
Sold states
Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.
Affected count
55,521 ea. in total
Manufactured in
2917 Weck Dr., N/A, Research Triangle Park, NC, United States
Products
Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm, 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1280-2014Don't want to check this manually?
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