FDA Device recall Z-1447-2015
Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416
- FDA Device
- Class II
- terminated
- Published 2015-04-22
On 2015-04-22 the FDA classified a Class II recall of Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416 by Bard Peripheral Vascular, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1447-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-17 |
| Published | 2015-04-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Lot Number: REYK1575, REYL0126, REYI1423, REYI2144, REYI2147, REYI2257, REYI2259, REYJ0186, REYJ0652, REYJ122…Lot Number: REYK1575, REYL0126, REYI1423, REYI2144, REYI2147, REYI2257, REYI2259, REYJ0186, REYJ0652, REYJ1221, REYJ2078, REYK0399, REYK0794, REYK1112, REYK1573, REYL0042, REYL0523, REYL1225. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1447-2015%22
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