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U.S. Department of Health and Human Services

Class 2 Device Recall Pentax Video Duodenoscope

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 Class 2 Device Recall Pentax Video Duodenoscopesee related information
Date Initiated by FirmJanuary 17, 2017
Create DateJuly 11, 2017
Recall Status1 Terminated 3 on March 08, 2018
Recall NumberZ-2713-2017
Recall Event ID 77308
510(K)NumberK092710 K963056 
Product Classification duodenoscope and accessories, flexible/rigid - Product Code FDT
ProductVideo Duodenoscope 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 is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.
Code Information Model Numbers: Ed-3490TK and ED-3270K
Recalling Firm/
Manufacturer		 Pentax of America Inc
3 Paragon Dr
Montvale NJ 07645-1782
For Additional Information ContactMr. Paul Silva
800-431-5880 Ext. 2064
Manufacturer Reason
for Recall		Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.
FDA Determined
Cause 2		Device Design
ActionThe firm, Pentax Medical, sent a "FIELD CORRECTION' letter dated January 17, 2017 to their affected customers via USPS Certified Mail. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove any affected product from use; follow product labeling; ensure all reprocessing personnel are knowledgeable and thoroughly trained on the instructions of Use for manual reprocessing of the devices; clean elevator recesses and follow all reprocessing instructions; and complete and return the FIELD CORRECTION RESPONSE FORM via a member of the PENTAX Service Department as part of an on-site-visit or Fax to: QA/RA Department at 201-799-4063 (alternate 201-391-4189) or a pdf copy to customeradvisiories@pentaxmedical.com. The firm will replace any affected product with its current generation model. If you have questions or request further information or assistance contact PENTAX Medical Customer Support at 1-800-431-5880 (8:30AM - 5:00PM, Monday-Friday, EST) or email: customeradvisories@pentaxmedical.com.
Quantity in Commerce 2,015 (US - 519 (ED-3490TK) and 5 (ED-3270K); OUS - 1,491)
DistributionWorldwide Distribution-US (Nationwide) including states of: AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, PR, TN, TX, UT, VA, WA, WI, WV, WY;. and country of: CANADA.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = FDT
510(K)s with Product Code = FDT
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