Device Recall

Prod Number: 0602290. Lot Numbers: RESF1061, RESI0209, RESI0672, RESI1072, RESK0055, RESK0806, RETA0584, RETC0929, RETF0739, RETH0830.

General Hospital and Personal Use Devices

Worldwide Distribution: Nationwide Distribution including the states of; AL, AR, AZ, CA, CT, DC, FL, GA, HI, IL, KY, LA, MA, MD, MI, MO, NJ, NV, NY, OK, PA, RI, SC, TN, TX, UT, VA, WI, and WV; and the countries of Canada and Belgium.

BardPort Titanium Implanted Port. || Bard Access Systems. || Assembled in Mexico. || A totally implantable vascular access device designed to provide long term repeated access to the vascular system

Lot 532109 (Use By 2013-12)

Cardiovascular Devices

2

No

Nationwide Distribution including the states of CA, GA, ID, MI, OH and PA.

ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801101, BALLOON DIAMETER 4MM, BALLOON LENGTH 2 CM, CATHETER LENGTH 40 CM, STERILE, MANUFACTURED IN USA AngioDynamics 603 Queensbury Avenue, Queensbury, NY 12804 || Cardiovascular catheterization

Lot 532794 (Use By 2013-12)

Cardiovascular Devices

2

No

Nationwide Distribution including the states of CA, GA, ID, MI, OH and PA.

ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801105, BALLOON DIAMETER 5MM, BALLOON LENGTH 4 CM, CATHETER LENGTH 40 CM, STERILE, MANUFACTURED IN USA AngioDynamics 603 Queensbury Avenue, Queensbury, NY 12804 || Cardiovascular catheterization

Lot C28712

Gastroenterology-Urology Devices

2

Yes

Nationwide distribution.

DURAMAX 15.5 F x 22 cm Chronic Hemodialysis Catheter Set (With Cuff 17 cm from Tip), DuraMax Stacked Tip 22 cm Str. Basic Kit, Catalog No./REF 10302802, STERILE --- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. || The AngioDynamics DuraMax¿ Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis.

Lots 500137, 500138, 527756, C28713

Gastroenterology-Urology Devices

2

Yes

Nationwide distribution.

DURAMAX 15.5 F x 24 cm Chronic Hemodialysis Catheter Set (With Cuff 19 cm from Tip), DuraMax Stacked Tip 24 cm Str. Basic Kit, Catalog No./REF 10302803, STERILE --- AngioDynamics, Inc. 603 Queensbury, NY 12804 USA || The AngioDynamics DuraMax¿ Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis.