—#127366

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.

FDA product code: GBZ — Catheter, Cholangiography
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Product Code 18400, Lot No. 01A1400037

Why it was recalled

Several complaints were received for the metal support tube missing from the cholangiogram catheter.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-05-16
Posted by FDA: 2014-06-12
Terminated: 2015-11-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127366. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.