Z-2713-2017 Class II Terminated
FDA device recall Z-2713-2017 was initiated by Pentax of America Inc on January 17, 2017 and is designated Class II. Reason for recall: Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal c… The recall status is terminated (terminated March 8, 2018). Affected quantity: 2,015 (US - 519 (ED-3490TK) and 5 (ED-3270K); OUS - 1,491).
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2017
- Initiation Date
- January 17, 2017
- Termination Date
- March 8, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,015 (US - 519 (ED-3490TK) and 5 (ED-3270K); OUS - 1,491)
Product Description
Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.
Reason for Recall
Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.
Distribution Pattern
Worldwide Distribution-US (Nationwide) including states of: AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, PR, TN, TX, UT, VA, WA, WI, WV, WY;. and country of: CANADA.
Code Information
Model Numbers: Ed-3490TK and ED-3270K