PENTAX Endoscopic Accessories 의 리콜

Recall

66379

Class 1

Z-0084-2014

2013-09-16

2013-10-28

Terminated

United States

2014-07-09

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122221

Pentax medical has become aware of a product issue associated with the of-b194 gas/water feeding valve. a manufacturing defect may cause improper stoppage of co2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.

PENTAX Medical sent an "Urgent Device Recall" notification letter with /Response forms dated September 16, 2013, via UPS Certified delivery to all affected customers. . The notification identified the affected product; informed the customers of the nature of the issue; advised of potential adverse patient consequences that may occur. The customer was asked to immediately examine their inventory and quarantine product subject to the recall. The customer was instructed to identify and notify their customers if they further distributed the product. The notification instructs users to return the OF-B194 Valves for replacement with corrected product. Customers were asked to complete the attached response form and fax back to Pentax Medical at 1.201.799.4063. An enclosed UPS Airway Bill is to be used to return recalled product. A contact phone number and email address is provided if the customer has questions (1.800.431.5880 xt2064). For questions regarding this recall call 800-431-5880. Pentax issued a press release on 10/31/2013. Pentax posted their press release on their website at www.pentax.com.