BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the

FDA device recall Z-1524-2013 · posted 2013-06-08 · Terminated

Recall details

Recalling firm

Bard Peripheral Vascular Inc

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FZP

Quantity affected

3,085

Distribution

Worldwide Distribution: USA Nationwide and Internationally to Europe.

Date initiated

2013-04-16

Date posted

2013-06-08

Date terminated

2014-01-30

Location

Tempe, AZ

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