Rocket Medical Plc: Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product Description: Chest tube manufactured

Hazard

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

Details from the source

Reason for recall: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. Distribution: 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 Quantity: 246 units Lot/code info: Model/Catalog Number: R54549-20-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496455, 499910, 496811, 500480, 496919, 501734, 497516, 503706, 499083, 504152;

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.