Device Recall AngioDynamics

Lot number: 983533

General Hospital and Personal Use Devices

2

Yes

AL, CA, CO, FL, GA, ID, IL, IN, KS, LA, MI, MO, MN, MS, NC, NY, OH, OR, PA, TN and TX.

SmartPort CT Port Access System, Catalog number CT80STPD, AngioDynamics Incorporated || The SmartPort CT Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for delivery of medications, nutritional supplementation, fluids, blood products, and sampling of blood.

Item Lot Manufacturing Number Number Date Expiration Date 10732203 119965U 11/7/2003 N/A 10732203 158623U 12/2/2003 N/A 10732203 175183U 3/22/2005 N/A 10732203 179688U 10/29/2004 N/A 10732203 191185U 12/5/2004 N/A 10732203 210813U 7/1/2005 N/A 10732203 225911U 10/27/2005 N/A 10732203 225918U 10/19/2005 N/A 10732203 225919U 10/17/2005 N/A 10732203 8248U 1/31/2006 N/A 10732203 253202U 2/23/2006 N/A 10732203 277726U 7/21/2006 N/A 10732203 302844U 12/14/2006 N/A 10732203 309329U 11/16/2006 N/A 10732203 325680U 12/30/2006 N/A 10732203 343908U 8/2/2008 N/A 10732203 352756U 8/11/2008 N/A 10732203 352761U 9/3/2008 N/A 10732203 359352U 2/6/2008 N/A 10732203 363987U 5/17/2008 N/A 10732203 366572U 10/18/2008 N/A 10732203 369818U 9/27/2008 N/A 10732203 375883U 9/20/2008 N/A 10732203 772102U 8/5/2004 N/A 10732203 773196U 12/18/2004 N/A 10732203 773216U 1/6/2005 N/A 10732203 775985U 3/16/2005 N/A 10732203 7710750U 8/3/2006 N/A

Cardiovascular Devices

2

No

Worldwide Distribution -- USA, to the states of TX, UT, PA, CA, VT, MA, WA, VA, NY, MD, and CT; and, the country of CANADA.

AngioDynamics Soft Vu Omni Flush Angiographic Catheter || Model Number: 10732203

Lot Numbers W24305, W24310, and W24311

Cardiovascular Devices

2

No

The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts.

AngioDynamics 14F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507601

Lot Numbers W24306 and W24313

Cardiovascular Devices

2

No

The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts.

AngioDynamics 15F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507602

Lot Numbers W24307, W24316, and W24317

Cardiovascular Devices

2

No

The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts.

AngioDynamics 16F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507603