Z-1524-2013 Class II Terminated
FDA device recall Z-1524-2013 was initiated by Bard Peripheral Vascular Inc on Apr 16, 2013 and is designated Class II. 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. The recall status is terminated (terminated Jan 30, 2014). Affected quantity: 3,085.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 19, 2013
- Initiation Date
- Apr 16, 2013
- Termination Date
- Jan 30, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,085
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution: USA Nationwide and Internationally to Europe.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1524-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026