Z-1524-2013Class II

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

Name: Z-1524-2013 BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast...
Creator: Bard Peripheral Vascular Inc
Published: 2013-04-16
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2013-04-16 / Terminated / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a recall of 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... on 2013-04-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1524-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-16
Posted: 2013-06-08
Terminated: 2014-01-30
Recalling firm: Bard Peripheral Vascular Inc
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.
Product code: FZP Clip, Implantable
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1524-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1524-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-08

Product code FZP

K993785Class IIUltraclip Tissue MarkerInrad / cleared 2000-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)