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.
This recall has been terminated (originally issued October 13, 2011).
- Company
- Angiodynamics, Inc
- Recall Initiated
- August 1, 2011
- Posted
- October 13, 2011
- Terminated
- March 7, 2012
- Recall Number
- Z-0055-2012
- Quantity
- 1095 total units
- Firm Location
- Manchester, GA
- Official Source
- View on FDA website ↗
Reason for Recall
The product may contain an incorrect size catheter and introducer.
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.
Lot / Code Info
Catalog number: V18, Lot numbers D1-01664 and D101799
Root Cause
Device Design
Action Taken
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 (800) 772-6446.