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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Product Detail

Product Description 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.
Recall Number Z-1529-2013
Classification Class II
Code Info PC USH07AT; Lot# FCWC10009
Product Distributed Qty 223
Reason For Recall 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).

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.
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