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Surgical Instruments

🏥 Medical Devices • 7,015 recalls

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.

Bard Peripheral Vascular

Class I - Dangerous

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.

Mar 17, 2015 Surgical Instruments Nationwide View Details →

Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: - An empty plastic syringe with Luer-Lok" tip - A plastic syringe with Luer-Lok" tip containing the Flowable Wound Matrix material - A syringe-to-syringe Luer-Lok" adapter / connector - A flexible plastic tube (injector) with Luer-Lok" connector Instructions for Use (IFU) and the sterilized package are subsequently packaged in a labeled and sealed box that is distributed to customers.

Integra LifeSciences

Class I - Dangerous

A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 was verified as not meeting stability acceptance criteria for the attributes of visual appearance during dispensing and force vs. displacement (force needed for product to be extruded from the syringe).

Mar 13, 2015 Surgical Instruments View Details →

INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.

Toshiba American Medical Systems

Class I - Dangerous

The table base rotational brake that holds the table top may not always be engaged when any force or side impact is applied to the table top.

Mar 11, 2015 Surgical Instruments Nationwide View Details →
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