Z-2186-2012Class III

TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC...

Name: Z-2186-2012 TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC...
Creator: Teleflex Medical
Published: 2012-07-20
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2012-07-20 / Terminated / root cause: packaging

FDA source

Teleflex Medical began a recall of TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. An introduction/drainage catheter accessory is... on 2012-07-20. FDA classified it as Class III and gives the reason as "Product is missing the label on the internal packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2186-2012
Classification: Class III
Status: Terminated
Initiated: 2012-07-20
Posted: 2012-08-10
Terminated: 2015-02-12
Recalling firm: Teleflex Medical
Product: TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body.
Product code: GBW Catheter, Peritoneal
Reason for recall: Product is missing the label on the internal packaging.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Consignees were notified by letter on 07/20/2012
Quantity in commerce: 611 units
Distribution: AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MI, MO, MS, NC, NY, OH, PA, SD, TX, UT, VA, WI, WV.
Product codes and lots: Catalog number: PI-128, Lot number: 01C200424, 01C1200425 and 01C1200426.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2186-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2186-2012	Class III	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-10

Product code GBW

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)