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Recall Observatory FDA recall evidence

Device 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.

Z-1524-2013

April 16, 2013

Class II

Product summary

Firm
Bard Peripheral Vascular Inc
Event
Event 65046
Status
Terminated
Classification
Class II
Quantity
3,085
Official record key
device-enforcement:Z-1524-2013

Official wording

Reason: 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.

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

Distribution pattern: Worldwide Distribution: USA Nationwide and Internationally to Europe.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.