—#126435

Product

5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Access Port - Long Length (100mm), Catalog No. 410944L; 5/10 Weck Vista Universal Balloon Open Access Port - Short Length (53mm), Catalog No. 410944S; 5/10/12 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 412944; 5/10/12 Weck Vista Universal Balloon Open Access Port - Long Length (100 mm), Catalog No. 412944L. 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: Lots Catalog No. 410944 - 01K1200601, 01K1200623, 01L1200355, 01L1200378, 01A1300203, 01D1300412, 01J1200241, 01K1200066, 01K1200622; Catalog No. 410944L - 01J1200219, 01K1200067, 01K1200600, 01L1200056, 01L1200354, 01A1300202, Catalog No. 410944S - 01L1200460, 01K1200619, 01L1200515, 01E1300137; Catalog No. 412944 01J1200241, 01K1200066, 01K1200622; Catalog No. 412944L - 01J1200231, 01K1200597, 01K1200618, 01K1200728, 01A1300178, 01D1300316, 01E1300310, 01E1300436

Why it was recalled

Complaints of leakage of insufflation gas through the device.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Letters were issued on March 11, 2014 to customers informing them of the recall. The letter asked the consignee to immediately discontinue use and quarantine any products on hand. The letter included a Recall Acknowledgement Form which is to be returned. A letter was also issued to distributors on March 11, 2014, requesting them to conduct a sub-recall.

Recalling firm

Firm: Teleflex Medical
Address: 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

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.

Timeline

Recall initiated: 2014-03-11
Posted by FDA: 2014-04-02
Terminated: 2016-01-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126435. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.