5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R; 5/10/12 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405912R. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Reported: April 9, 2014 Initiated: March 11, 2014 #Z-1325-2014
Product Description
5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R; 5/10/12 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405912R. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Reason for Recall
Complaints of leakage of insufflation gas through the device.
Details
- Recalling Firm
- Teleflex Medical
- Units Affected
- 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.
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R; 5/10/12 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405912R. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.. Recalled by Teleflex Medical. Units affected: 55,521 total.
Why was this product recalled? ▼
Complaints of leakage of insufflation gas through the device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 9, 2014. Severity: Moderate. Recall number: Z-1325-2014.
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