Device product
Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 100mm, Catalog No. 405912; Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 125mm, Catalog No. 40591213. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Z-1323-2014
Product summary
- Firm
- Teleflex Medical
- Event
- Event 67819
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55,521 total
- Official record key
device-enforcement:Z-1323-2014
Official wording
Reason: Complaints of leakage of insufflation gas through the device.
Code information: Lots Catalog No. 405910 - 01G1200242, 01G1200242, 01G1200341, 01J1200100, 01J1200100, 01J1200378, 01J1200461, 01K1200266, 01K1200171, 01K1200266, 01L1200182, 01A1300139, 01A1300139, 01B1300050, 01D1300318, 01E1300139, 01E1300217, 01E1300432; Catalog No. 405912 01J1200462, 01K1200129, 01K1200377, 01K1200596, 01K1200611, 01K1200611, 01L1200369, 01L1200369, 01L1200369, 01A1300106, 01A1300106, 01A1300106, 01E1300218, 01E1300311, 01F1300135, 01F1300079; Catalog No. 40591213- 01J1200416, 01K1200612, 01L1200160, 01A1300418, 01A1300427, 01E1300056, 01E1300052, 01E1300055
Distribution pattern: 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.
Derived failure modes
-
Unknown
Complaints of leakage of insufflation gas through the device.