Date Initiated by Firm | September 16, 2013 |
Date Posted | October 28, 2013 |
Recall Status1 |
Terminated 3 on July 09, 2014 |
Recall Number | Z-0084-2014 |
Recall Event ID |
66379 |
510(K)Number | K850020 |
Product Classification |
Insufflator, automatic carbon-dioxide for endoscope - Product Code FCX
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Product | PENTAX Endoscopic Accessories. OF-B194. Made in Japan.
PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation. |
Code Information |
Model OF-B194 |
Recalling Firm/ Manufacturer |
Pentax Medical Company 3 Paragon Dr Montvale NJ 07645-1782
|
For Additional Information Contact | Mr. Paul Silva 800-431-5880 Ext. 2064 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | Use error |
Action | 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. |
Quantity in Commerce | 76 units |
Distribution | Nationwide Distribution including Arizona, California, Florida, Idaho, Indiana, Kansas, Maryland, Missouri, Missippi, North Carolina, New York, Pennsylvania, Virginia, Wisconsin and Wyoming. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = FCX
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