Pentax Choledochoscope Recall Due to Potential Instrument Channel Lodging
Pentax Medical is recalling 50 units of FCP-8P and FCP-9P choledochoscopes because accessories and therapeutic devices may become lodged in the instrument channel.
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Pentax Medical Company is recalling 50 units of the FCP-8P and FCP-9P choledochoscopes. These medical devices are intended to provide optical visualization of and therapeutic access to the Biliary Tree, including the Common Bile, Hepatic, Cystic, and Pancreatic Ducts. The instruments are introduced via the working channel of a Duodenoscope for adult and pediatric patients.
The recall was initiated because Pentax has become aware that operational/cleaning accessories and therapeutic devices, such as clips, stents, and balloons, can become lodged in the endoscope's instrument channel. This issue may affect the functionality of the device during procedures.
The affected units were distributed worldwide, including nationwide in the United States (including Puerto Rico) and internationally to Denmark and Guam. Healthcare providers and facilities should stop using the affected devices and contact Pentax Medical Company for further instructions on the recall.
The recalled product
- Product
- Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the w
- Manufacturer
- Pentax Medical Company
- Category
- Medical Device — Endoscopes
- Affected units
- 50
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)
- Model #'s FCP-8P and FCP-9P
Distribution
Part of a larger recall action
This product is one of 16 recalled by Pentax Medical Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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