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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 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).
Recall Number Z-1526-2013
Classification Class II
Code Info PC 864017D; Lots: HUWK1296, HUWK1297
Product Distributed Qty 815
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.