FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: 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.
- Recall number
- Z-1524-2013
- 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.
- Status
- Terminated
- Initiated
- 2013-04-16
- Posted
- 2013-06-08
- Terminated
- 2014-01-30
- 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.
- 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
- 3,085
- Distribution
- Worldwide Distribution: USA Nationwide and Internationally to Europe.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K993785"]
- PMA numbers
- not on file
- Product code
- FZP
- Firm FEI
- 2020394
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28