—#126121

Product

5/10 Weck Vista" Universal Balloon Open Access Port Short Length (53mm), 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 product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K112456
Affected lot / code info: Product Code: 410944S, Lot Numbers: 01J1200460, 01K1200619, 01L1200515, and 01E1300137.

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr., Research Triangle Park, North Carolina 27709

Distribution

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

Timeline

Recall initiated: 2014-03-11
Posted by FDA: 2014-03-25
Terminated: 2017-08-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126121. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.