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U.S. Department of Health and Human Services

Class 2 Device Recall Cholangioscopy Access Balloon

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  Class 2 Device Recall Cholangioscopy Access Balloon see related information
Date Initiated by Firm December 23, 2010
Date Posted January 19, 2011
Recall Status1 Terminated 3 on August 04, 2011
Recall Number Z-0926-2011
Recall Event ID 57573
510(K)Number K101095  
Product Classification Catherer, biliary, diagnostic - Product Code FGE
Product DPOC-20, Direct Peroral Cholangioscopy Balloon, G54951, 20 mm/17 mL, Rx Only, Cook Medical, Winston-Salem, NC 27105

This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.
Code Information DPOC-20, Lot number: W2834631
Recalling Firm/
Manufacturer
Cook Endoscopy
5951 Grassy Creek Blvd
Winston Salem NC 27105-1206
For Additional Information Contact Customer Relations
800-457-4500 Ext. 2146
Manufacturer Reason
for Recall
There is a risk of gastrointestinal perforation or air embolism due to balloon deflation difficulty, resulting in poor patient outcomes.
FDA Determined
Cause 2
Other
Action The firm, Cook Medical, sent an "URGENT: PRODUCT RECALL" letter dated January 7, 2011, to all customers. The letter described the product, problem and the actions to be taken by the customers. The customers were instructed to quarantine any affected product and return to Cook Medical. If they are distributors, they were instructed to contact their customers, direct them to quarantine any affected product and coordinate the return of the affected product to Cook Medical. The customers were also instructed to complete and return the bottom of the letter and send to Cook Medical as well as the PRODUCT RECALL EFFECTIVENESS SURVEY via fax at 812-339-7316 or scanned and emailed to CustomerRelationsNA@cookmedical.com. Note: All non-responding customers will receive a total of three (3) recall notifications ( two (2) follow up requests for a response in addition to the initial recall notification). Should you have any questions, please contact the Customer Relations Department at Cook Medical for more information. Please use CustomerRelationsNA@cookmedical.com or call toll free at 1-800-457-4500, press 4 then enter extension 2146.
Quantity in Commerce see line 1.
Distribution Worldwide distribution: USA including states of: AL, CA, FL, IL, IN, LA, MA, NC, NY, OH, PA, SC, TN, TX, WA, and WI; and countries of: Belgium, Canada, Germany, Hong Kong, and the Netherlands..
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FGE and Original Applicant = WILSON-COOK MEDICAL, INC.
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