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.
FDA Recall Z-1280-2014 · Posted 2014-03-25
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Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeGCJ
Date Initiated2014-03-11
Date Terminated2017-08-15
Product Quantity55,521 ea. in total
Reason for Recall
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
Firm Action
Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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