PlainRecalls
FDA Devices Moderate Class II Terminated

10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.

Reported: April 9, 2014 Initiated: March 11, 2014 #Z-1324-2014

Product Description

10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.

Reason for Recall

Complaints of leakage of insufflation gas through the device.

Details

Recalling Firm
Teleflex Medical
Units Affected
55,521 total
Distribution
Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.
Location
Durham, NC

Frequently Asked Questions

What product was recalled?
10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.. Recalled by Teleflex Medical. Units affected: 55,521 total.
Why was this product recalled?
Complaints of leakage of insufflation gas through the device.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 9, 2014. Severity: Moderate. Recall number: Z-1324-2014.