Recall Z-0055-2012 ยท DYB Introducer, Catheter
Angiodynamics, INC
8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedure.
| Date | Oct 13, 2011 (initiated Aug 1, 2011) |
| Status | Terminated |
| Reason | The product may contain an incorrect size catheter and introducer. |
| Root cause | Device Design |
| Action | AngioDynamics, Inc contacted affected customers initially via telephone and a follow up "Notification of Medical Device Correction" letter was sent dated August 1, 2011. The letter informed them of the problem and provided instructions. Customers were instructed to utilize the 8F Introducer Sheath provided within the 8F Smart Port CT Implantable Port during port implantation. The 8F Valved Sheath (V18) may continue to be utilized during the placement of the 7.5F Smart Port Implantable Port (for example: CT75STSD; CT75STSD-NF). For question on this recall contact AngioDynamics, Inc at |
| Quantity | 1095 total units |
| Distribution | (USA) Nationwide distribution including the states of CA, FL, GA, IA, IL, IN, KY, MD, MI, MO, NC, NE, NJ, NY, OH, OK, OR, TN, UT, WA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073100 | INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S Oscor, Inc., Nov 30, 2007 |