Recall Z-1328-2014 ยท GCJ Laparoscope, General & Plastic Surgery
Teleflex Medical
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
| 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
| K112456 | ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT Teleflexmedical, Inc., Oct 4, 2011 |