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Recall Observatory FDA recall evidence

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

March 11, 2014

Class II

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

    reason.no_named_rule · v1.0.0

    Complaints of leakage of insufflation gas through the device.