Recall Z-0055-2012
Angiodynamics, INC · initiated August 1, 2011
Product
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.
Codes / lots: Catalog number: V18, Lot numbers D1-01664 and D101799
Reason for recall
The product may contain an incorrect size catheter and introducer.
FDA-determined 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.
Details
- Recall number
- Z-0055-2012
- Initiated
- August 1, 2011
- Posted by FDA
- October 13, 2011
- Terminated
- March 7, 2012
- Product code
- DYB – Introducer, Catheter
- 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.
- Recalling firm
- Angiodynamics, INC, Manchester, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0056-2012 | 8F Smart Port CT, Catalog number: CT80STPD and CT80STPD-NF; AngioDynamics, INC. The…The product may contain an incorrect size catheter and introducer. | 08/01/2011Terminated |