Z-1447-2015 Class II Terminated
FDA device recall Z-1447-2015 was initiated by Bard Peripheral Vascular Inc on Mar 17, 2015 and is designated Class II. Reason for recall: Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because they may be at risk of having activation-related issues. The recall status is terminated (terminated Aug 3, 2015). Affected quantity: 29,342 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 22, 2015
- Initiation Date
- Mar 17, 2015
- Termination Date
- Aug 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29,342 units
Product Description
Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), Product Code: 211410. The BARD MONOPTY Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The actuator button and arrow in the ready window are color coded according to the various gauge sizes, e.g., Yellow=20 gauge, Pink=18 gauge, Purple=16 gauge, Green=14 gauge, and Light Blue=12 gauge. (Only the 14 gauge size has been reported to be affected by this issue). The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Reason for Recall
Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because they may be at risk of having activation-related issues.
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: Denmark, Spain, Finland, France, Ireland, Israel, Italy, Netherlands, Poland, Japan and Pakistan.
Code Information
Lot Number: REYK1575, REYL0126, REYI1423, REYI2144, REYI2147, REYI2257, REYI2259, REYJ0186, REYJ0652, REYJ1221, REYJ2078, REYK0399, REYK0794, REYK1112, REYK1573, REYL0042, REYL0523, REYL1225.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1447-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026