Recall Z-1323-2014
Teleflex Medical · initiated March 11, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 100mm, Catalog No. 405912; Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 125mm, Catalog No. 40591213. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Codes / lots: Lots Catalog No. 405910 - 01G1200242, 01G1200242, 01G1200341, 01J1200100, 01J1200100, 01J1200378, 01J1200461, 01K1200266, 01K1200171, 01K1200266, 01L1200182, 01A1300139, 01A1300139, 01B1300050, 01D1300318, 01E1300139, 01E1300217, 01E1300432; Catalog No. 405912 01J1200462, 01K1200129, 01K1200377, 01K1200596, 01K1200611, 01K1200611, 01L1200369, 01L1200369, 01L1200369, 01A1300106, 01A1300106, 01A1300106, 01E1300218, 01E1300311, 01F1300135, 01F1300079; Catalog No. 40591213- 01J1200416, 01K1200612, 01L1200160, 01A1300418, 01A1300427, 01E1300056, 01E1300052, 01E1300055
Reason for recall
Complaints of leakage of insufflation gas through the device.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1323-2014
- Initiated
- March 11, 2014
- Posted by FDA
- April 2, 2014
- Terminated
- January 28, 2016
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- 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, and Vietnam.
- Recalling firm
- Teleflex Medical, Durham, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1324-2014 Class II | 10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog…Complaints of leakage of insufflation gas through the device. | 03/11/2014Terminated |
| Z-1325-2014 Class II | 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R…Complaints of leakage of insufflation gas through the device. | 03/11/2014Terminated |
| Z-1326-2014 Class II | 5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck Vista…Complaints of leakage of insufflation gas through the device. | 03/11/2014Terminated |
| Z-1327-2014 Class II | 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An…Complaints of leakage of insufflation gas through the device. | 03/11/2014Terminated |
| Z-1328-2014 Class II | 5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No.…Complaints of leakage of insufflation gas through the device. | 03/11/2014Terminated |