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U.S. Department of Health and Human Services

Class 2 Device Recall Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm

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  Class 2 Device Recall Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm see related information
Date Initiated by Firm May 16, 2014
Date Posted June 12, 2014
Recall Status1 Terminated 3 on November 04, 2015
Recall Number Z-1786-2014
Recall Event ID 68332
Product Classification Catheter, cholangiography - Product Code GBZ
Product Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm

To facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystectomy.
Code Information Product Code 18400, Lot No. 01A1400037
Recalling Firm/
Manufacturer		 Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information Contact Michael Taggart
919-433-4829
Manufacturer Reason
for Recall		 Several complaints were received for the metal support tube missing from the cholangiogram catheter.
FDA Determined
Cause 2		 Employee error
Action Teleflex sent an Urgent Medical Device Recall Notification dated May 16, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were Instructed: 1. Immediately discontinue distribution and quarantine any products with the catalog numbers and lot numbers listed above. 2. Using the provided customer letter and Recall Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. In the event that an alternative approach is needed, contact Teleflex Medical Customer Service for more information at 1-866-246-6990. 4. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1- 866-804-9881, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical. 5. If you and your customers have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. This will allow us to document your receipt of this letter Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce 450
Distribution Worldwide Distribution - USA including the states of AL, AZ, AR, CA, CO, FL, IL, LA, ME, MI, MO, NY, OH, OR, TN, TX, VT and WI., and the country of Belgium.
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.
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