Z-1786-2014Class II

Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction of contrast media...

Name: Z-1786-2014 Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction of contrast media...
Creator: Teleflex Medical
Published: 2014-05-16
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-05-16 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of 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... on 2014-05-16. FDA classified it as Class II and gives the reason as "Several complaints were received for the metal support tube missing from the cholangiogram catheter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1786-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-16
Posted: 2014-06-12
Terminated: 2015-11-04
Recalling firm: Teleflex Medical
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.
Product code: GBZ Catheter, Cholangiography
Reason for recall: Several complaints were received for the metal support tube missing from the cholangiogram catheter.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Product Code 18400, Lot No. 01A1400037

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1786-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1786-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-12

Product code GBZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)