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Recall Observatory FDA recall evidence

Device product

5/10/12 mm Weck¿ Vista" Universal Cannula, 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.

Z-1284-2014

March 11, 2014

Class II

Product summary

Firm
Teleflex Medical
Event
Event 67710
Status
Terminated
Classification
Class II
Quantity
55,521 ea. in total
Official record key
device-enforcement:Z-1284-2014

Official wording

Reason: Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Code information: Product Code: 405912C, Lot Numbers: 01J1200384, 01K1200725, 01L1200352, and 01B1300009.

Distribution pattern: Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.