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.
Z-0414-2022
Product summary
- Firm
- Cook Inc.
- Event
- Event 89104
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 112 US, 240 OUS
- Official record key
device-enforcement:Z-0414-2022
Official wording
Reason: 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.
Code information: 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
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.