FDA recall Z-0414-2022

Cook Inc. · Class II · device

Product

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.

Reason for recall

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.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2021-10-13
Report date
2021-12-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0414-2022