Device Recall Bard

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

Product Number: 0607173  Lot Numbers: RESF0856, RESH0067, RESH1150.

General Hospital and Personal Use Devices

2

Yes

Worldwide Distribution -- USA, including the states of CA, CT, FL, KS, IL, MI, MN, OH, OK, SD, TN, TX, VA, WA and the country of Belgium.

BardPort M.R.I. Implanted Port with Attachable 6 Fr. ChronoFlex Open-Ended Single-Lumen Venous Catheter and Peel-Apart Introducer Kit. Subcutaneous implanted intravascular infusion port and catheter is used to provide repeated access to the vascular system for the delivery of medications, intravenous fluids, parenteral nutrition solutions, and blood products. They are also indicated for the withdrawal of blood samples.

Catalog No. 300316A (Lot Nos. - NGVJ1108, NGVJ1712, NGVJ1713, NGVJ1105, NGVJ1714) Catalog No. 898316 (Lot Nos. NGVJ1614, NGVJ1615, NGVJ1616, NGVJ1617) Catalog No. 897414 (Lot No. NGVJ1705) Catalog No. 907618 (Lot No. NGVJ1757) Catalog No. 907600 (Lot No. NGVJ1764)

Gastroenterology-Urology Devices

2

No

Nationwide distribution: USA

Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. || Used to catheterize patients. The finished trays are sold in Tyvek breather bags.

PC 864017D; Lots: HUWK1296, HUWK1297

General and Plastic Surgery Devices

2

Yes

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY.

BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. || PK4320100 Rev. 0 03/10 || The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).

PC 863017D; Lot: HUWL0010

General and Plastic Surgery Devices

2

Yes

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY.

BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4313800 Rev. 1 01/11 || The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).