Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

Code information: Model/Catalog Number: R54544-12-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496708, 501186, 496903, 501548, 497147, 502122, 497292, 502317, 497344, 502534, 497664, 502949, 499226, 503201, 499276, 503429, 499415, 503732, 499462, 503899, 499806, 503935, 499902, 504283, 500404, 504581, 500474, 504637, 500757, 504821, 500955, 505025;

Distribution pattern: Domestic: CO, CT, IL, MA, ME, NH, NJ, NM, OH, RI, SC, TX; International: UAE, Austria, Australia, Canada, Germany, Denmark, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, India, Italy, Jersey, Kenya, Sri Lanka, Malta, Netherlands, Norway, New Zealand, Portugal, Saudi Arabia, Singapore, Slovenia, South Africa