Recall Z-2100-2015 ยท GBZ Catheter, Cholangiography
Cook Inc.
Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrahepatic Access Set consists of the following components: Flexor RTPS Guiding Sheath, needle, catheter, Dilator, Torcon NB Advantage Catheter, Van Andel Dilatation Catheter, Curved
| Date | Jul 18, 2015 (initiated May 28, 2015) |
| Status | Terminated |
| Reason | Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long. |
| Root cause | Component change control |
| Action | Written recall communication letters were shipped via FedEx on June 05, 2015 to all US Consignees. Customers were asked to complete and return response forms and recalled products. Recalled devices will be held for final disposition and destruction. Customers wree asked to forward notices if recalled devices were further distributed. Effectivenes checks will be conducted by mail, phone and visits. Customers may contact Cook Medical Relations (800) 457-4500 or 1 (812)- 339-2235 Monday through Friday from 7:30 AM to 5:00 PM or e-mail at CustomerrelationsNA@cook medical.com. |
| Quantity | 661 |
| Distribution | Worldwide Distribution - US Nationwide in the state of: AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Canada and EU. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.