Recall Z-1288-2014 ยท GCJ Laparoscope, General & Plastic Surgery
Teleflex Medical
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.
| Date | Mar 25, 2014 (initiated Mar 11, 2014) |
| Status | Terminated |
| Reason | 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 | Nonconforming Material/Component |
| 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. |
| Quantity | 55,521 ea. in total |
| Distribution | Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112456 | ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT Teleflexmedical, Inc., Oct 4, 2011 |