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FDA Medical Device Recalls (openFDA)

Teleflex Medical: 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.

Recall number
Z-2186-2012
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.
Status
Terminated
Initiated
2012-07-20
Posted
2012-08-10
Terminated
2015-02-12
Reason
Product is missing the label on the internal packaging.
Root cause
Packaging process control
Action
Consignees were notified by letter on 07/20/2012
Quantity
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.
Lot, serial or model codes
Catalog number: PI-128, Lot number: 01C200424, 01C1200425 and 01C1200426.
510(k) numbers
not on file
PMA numbers
not on file
Product code
GBW
Firm FEI
3005747797
Firm city
Research Triangle Park
Firm state
NC
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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