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
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
Product is missing the label on the internal packaging.