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U.S. Department of Health and Human Services

Enforcement Report - Week of April 2, 2014

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Product Detail

Product Description 5/10 mm Weck®, Vista" Optical Bladeless Laparoscopic Access Port, 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.
Recall Number Z-1278-2014
Classification Class II
Code Info Product Code: 405933, Lot Numbers: 01L1200353, and 01F1300080.
Product Distributed Qty 55,521 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.

Event Detail

Event Id 67710
Product Type Devices
Status Ongoing
Recalling Firm Teleflex Medical
City Research Triangle Park
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.
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