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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Event Detail

Event ID 64276
Product Type Devices
Status Terminated
Recalling Firm Bard Peripheral Vascular Inc
City Tempe
State AZ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-23
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
USHER® Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; Manuf: FlowCardia, Inc., a Subsidiary of C. R. Bard, Inc., 745 North Pastoria Ave, Sunnyvale CA 95085. The Usher® Peripheral is a single lumen support catheter, with a standard luer fitting at the proximal end. The Usher® Peripheral is available in a length 130 cm with an angled tip shape. PC USH07AT; Lot# FCWC10009 Class II Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard® UltraClip® Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile). 223 Z-1529-2013
MICROSHEATH® - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia, Inc., a Subsidiary of C.R. Bard, Inc. 745 North Pastoria Ave., Sunnyvale, CA 94085. The MicroSheath and Usher Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature. MicroSheath® is a single lumen catheter that has a 123cm working length and a straight tip shape PC MS17123; Lot# FCWC10010 Class II Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard® UltraClip® Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile). 17 Z-1528-2013
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). PC 863017D; Lot: HUWL0010 Class II Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard® UltraClip® Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile). 315 Z-1527-2013
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 864017D; Lots: HUWK1296, HUWK1297 Class II Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard® UltraClip® Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile). 815 Z-1526-2013
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