FDA-Device2016-08-24Class II

Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.

Bard Peripheral Vascular Inc
Hazard

May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.

Sold states
Nationwide Distribution to the following; CA, LA, VA, IA, AR, SC, PA, MA, IL, MO. Foreign distribution to the following; Canada, Belgium, Australia, Taiwan, China, Argentina.
Affected count
1250 units
Manufactured in
1625 W 3rd St, N/A, Tempe, AZ, United States
Products
Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2547-2016

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