Recalls / —
—#111121
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.
- FDA product code
- GBW — Catheter, Peritoneal
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- Catalog number: PI-128, Lot number: 01C200424, 01C1200425 and 01C1200426.
Why it was recalled
Product is missing the label on the internal packaging.
Root cause (FDA determination)
Packaging process control
Action the firm took
Consignees were notified by letter on 07/20/2012
Recalling firm
- Firm
- Teleflex Medical
- Address
- 2917 Weck Dr., Research Triangle Park, North Carolina 27709
Distribution
- 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.
Timeline
- Recall initiated
- 2012-07-20
- Posted by FDA
- 2012-08-10
- Terminated
- 2015-02-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #111121. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.