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U.S. Department of Health and Human Services

Class 2 Device Recall UltraClip Dual Trigger breast tissue marker

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 Class 2 Recall
UltraClip Dual Trigger breast tissue marker
see related information
Date Posted June 08, 2013
Recall Status1 Terminated on January 30, 2014
Recall Number Z-1524-2013
Recall Event ID 65046
Premarket Notification
510(K) Number
K993785 
Product Classification Clip, Implantable - Product Code FZP
Product BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.
Code Information Affected Product Lots with the following Product Code and Lot Number combinations. Product Code 864017D 864017D 864017D 864017D 864017D 864017D 864017D 864017DL Lot Number HUWI1522 HUWI1941 HUWI1942 HUWI1943 HUWJ1851 HUWJ1852 HUWK0350 HUWJ1610
Recalling Firm/
Manufacturer
Bard Peripheral Vascular Inc
1625 W 3rd St Ste 109
Tempe, Arizona 85281-2438
Manufacturer Reason
for Recall
Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number combination may have the metal tissue marker separated from the needle prior to use.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Bard Peripheral Vascular, Inc. initiated a recall of certain product code and lot number combinations of Bard UltraClip Dual Trigger Tissue Marker by contacting customers on 04/16/2013. On 04/18/2013, BPV sent a Customer Recall notification Letter via FedEx with proof of delivery notice. The letter included reason for recall, a table of affected product code and lot numbers, instructions (Do not use or further distribute any affected product), a response form (titled Recall and Effectiveness Check Form) enclosed, and contact information.
Quantity in Commerce 3,085
Distribution Worldwide Distribution: USA Nationwide and Internationally to Europe.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FZP and Original Applicant = INRAD
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