Recall Class: Class I
Date Recall Initiated: September 16, 2013
Products: PENTAX Gas/ Water Valve, Model OF-B194
The product was manufactured from April 2009 through August 2013 and distributed from April 2009 through September 2013.
The product can be identified by the model number (OF-B194) stamped on the valve. Corrected valves have a circle before the model number (O OF-B194)
ALL OF THE UNITS DISTRIBUTED IN THE UNITED STATES AND WORLDWIDE HAVE BEEN RECALLED.
Use: The gas/water valve is used with upper G.I. (gastrointestinal) endoscopes to deliver a non-explosive gas (CO2) into a body cavity
Pentax Medical Company
3 Paragon Drive
Montvale, New Jersey 07645-1782
Reason for Recall: The OF-B194 Valve has been found to have a manufacturing defect which may prevent users from turning off the CO2 gas flow during an endoscopic procedure with the potential for serious hazard to the patient, including peritonitis, perforations, sepsis, bowel perforations requiring surgical repair, and death.
Public Contact: Customers with questions may contact the company by telephone at 1-800-431-5888 extension 2064 and speak to the Recall Coordinator Paul Silva between the hours of 9:00am and 5:00pm Eastern Standard Time. Customers may also contact the company by email at PAMC-RA-Group@pentaxmedical.com.
FDA District: New Jersey District Office
On September 16, 2013 the firm sent its customers an “Urgent Device Recall” letter with a response form to all affected customers. The notice identified the affected product, informed the customer of the nature of the issue, and advised the potential adverse patient consequences that may occur. The company asked their customers to:
- Immediately examine and quarantine their recalled inventory.
- Stop using the recalled product.
- Identify and notify their customers if they further distributed the recalled product.
- Return the OF-B194 valves for replacement with corrected products.
- Complete the attached response form and fax it back to Pentax Medical at 1-201-799-4063. (An enclosed USP Airway Bill is to be used to return the recalled product).
- Contact the firm at 1-800-431-5880, ext. 2064 with any questions regarding this recall.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.