Reported Apr 22, 2015 · Terminated
Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty…
Bard Peripheral Vascular Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bard Peripheral Vascular Inc · 1625 W 3rd St Ste 109 · Tempe, AZ · 85281-2438
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
121416 | Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm) |
000441 | Monopty Biopsy |
121410 | Monopty 14g x 10cm (22mm) |
211410. | Monopty 14g x 10cm (11mm), 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. |
- Lot codes and dates
- Lot Number
REYK1575REYL0126REYI1423REYI2144REYI2147REYI2257REYI2259REYJ0186REYJ0652REYJ1221REYJ2078REYK0399REYK0794REYK1112REYK1573REYL0042REYL0523REYL1225
- Lot Number
- Amount recalled
- 29,342 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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