Recall Z-1327-2014 ยท GCJ Laparoscope, General & Plastic Surgery
Teleflex Medical
5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
| Date | Apr 2, 2014 (initiated Mar 11, 2014) |
| Status | Terminated |
| Reason | Complaints of leakage of insufflation gas through the device. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 55,521 total |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021731 | ADAPT OPEN ACCESS PORT, MODEL 41233 Taut, Inc., Aug 8, 2002 |