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Terminated

MR Coaxial 10g x 140mm (VC10140MR).

FDA Recall Z-1881-2009 · Posted 2009-08-26

Recalling FirmBard Peripheral Vas
Recall StatusTerminated
Product CodeDWF
Date Initiated2009-03-26
Date Terminated2012-04-02
Product Quantity695

Reason for Recall

Some Vacora 10G Plastic Coaxial Cannulas may leave a small metal filament in the breast or the sample obtained post procedure.

Firm Action

Bard Peripheral Vascular, Inc. issued an "Urgent Medical Device Recall Notification" dated March 27, 2009 informing Customers of the affected devices. The firm requested that all affected product be removed and returned along with returning a Recall and Effectiveness Check Form via fax. For further information, contact Bard Peripheral Vascular, Inc. at 1-800-321-4254.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082681VACORA VACUUM ASSISTED BIOPSY SYSTEMC.R. Bard, Inc. · 2008-10-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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