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Recall Observatory FDA recall evidence

Device 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.

Z-2186-2012

July 20, 2012

Class III

Product summary

Firm
Teleflex Medical
Event
Event 62598
Status
Terminated
Classification
Class III
Quantity
611 units
Official record key
device-enforcement:Z-2186-2012

Official wording

Reason: Product is missing the label on the internal packaging.

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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product is missing the label on the internal packaging.