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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 Device Recall UltraClip Dual Trigger breast tissue marker see related information
Date Initiated by Firm April 16, 2013
Date Posted June 08, 2013
Recall Status1 Terminated 3 on January 30, 2014
Recall Number Z-1524-2013
Recall Event ID 65046
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 AZ 85281-2438
For Additional Information Contact
480-894-9515
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FZP and Original Applicant = INRAD
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