Pentax Video Duodenoscope Recalled to Mitigate Infection Risk
Pentax of America Inc is recalling 559 Video Duodenoscopes to replace specific components and update inspection protocols to mitigate the potential risk of infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall addresses a 'potential risk of infection' in a medical device without reported illnesses or injuries, which aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Pentax of America Inc is recalling 559 units of the Pentax Video Duodenoscope, Model ED-3490TK. These instruments are intended to provide optical visualization and therapeutic access to the biliary tract via the upper GI tract. The recall covers all serial numbers of the affected design.
The recall is being conducted to replace the forceps elevator mechanism, O-rings, and distal end covering to align with an updated design. Additionally, the recall includes providing an updated periodic inspection protocol as part of the Operation Manual. These measures are intended to mitigate the potential risk of infection associated with flexible endoscopy.
The affected devices were distributed nationwide in the United States, including Puerto Rico and the District of Columbia. Specific states listed include AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV, and WY. Users should contact Pentax of America Inc for instructions on replacing the components and updating their inspection procedures.
The recalled product
- Product
- Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) 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
- Manufacturer
- Pentax of America Inc
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 559
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial Numbers
Distribution
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