FDA-Device2021-12-29Class II
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.
Cook Inc.
Hazard
Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AL, CA, IN, LA, MS, MT, NC, NY, OR, PA, WA and the countries of France, Italy, and Mexico.
Affected count
112 US, 240 OUS
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0414-2022Don't want to check this manually?
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