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.
Check against the official notice below — it lists the full affected range.
Cook Inc. is recalling specific lots of Skinny Needle with Chiba Tip rigid needles (model numbers RPN 090010 and 090010-ET) distributed worldwide, including in the US states of Alabama, California, Indiana, Louisiana, Mississippi, Montana, North Carolina, New York, Oregon, and Pennsylvania, as well as France, Italy, and Mexico. The recalled products may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula, which could cause local inflammatory reactions if the product is used.
The affected lots are identified by specific lot numbers and UDI codes listed in the recall notice. According to the source record, no remedy is specified for consumers who may have this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 112 US, 240 OUS Lot/code info: RPN 090010/GPN G14254: LOT NUMBER UDI 13977925 (01)00827002142541(17)240524(10)13977925 14030949 (01)00827002142541(17)240617(10)14030949 14054162 (01)00827002142541(17)240628(10)14054162 14116047 (01)00827002142541(17)240728(10)14116047 RPN 090010-ET/GPN G15290: LOT NUMBER UDI 14038615 (01)00827002152901(17)240618(10)14038615
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.