CLASS III Device recall · Reported 22 Aug 2012 · FDA Enforcement Report

TAUT, Cholangiogram Catheter Intraducer recalled by Teleflex Medical

Teleflex Medical is recalling TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research, distributed in 26 states. The recall was initiated on 20 Jul 2012 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesCatalog number: PI-128, Lot number: 01C200424, 01C1200425 and 01C1200426.

Quantity recalled611 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2186-2012
FDA event ID: 62598
Recalling firm: Teleflex Medical, Research Triangle Park, NC
Classification: Class III
Status: Terminated
Recall initiated: 20 Jul 2012
FDA classified: 10 Aug 2012
Reported: 22 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

20 Jul 2012	Recall initiated by company
10 Aug 2012	Classified by FDA	+21 days
22 Aug 2012	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product is missing the label on the internal packaging.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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.

Alaska Alabama Arizona California Colorado Florida Georgia Iowa Illinois Indiana Kansas Louisiana Massachusetts Michigan Missouri Mississippi North Carolina New York Ohio Pennsylvania

Questions about this recall

Why was it recalled?

Product is missing the label on the internal packaging.

Which lots are affected?

Catalog number: PI-128, Lot number: 01C200424, 01C1200425 and 01C1200426.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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