FDA-Device2013-06-19Class II
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.
Bard Peripheral Vascular Inc
Hazard
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.
Sold states
Worldwide Distribution: USA Nationwide and Internationally to Europe.
Affected count
3,085
Manufactured in
1625 W 3rd St Ste 109, N/A, Tempe, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1524-2013Don't want to check this manually?
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