United StatesRocket Medical Plc is recalling Rocket 12Fg, 16Fg, 18Fg and 20Fg Seldinger catheter procedure trays and Seldinger catheters with Safety Guard (models R54544-12-PK, R54544-12-SG, R54544-18-PK, R54544-18-SG, R54549-16-PK, R54549-20-PK), which are PVC chest tubes with fenestrations and a barium stripe supplied in percutaneous procedure packs with connectors. The recall was issued because the IFU and device kit labeling contain misleading statements that can lead to improper securing of the device and the potential for the tube to fall out during use.
What's being recalled
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
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A 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
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A 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
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A 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.
Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A 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
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 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
Recalling firm: Rocket Medical Plc, Tyne & Wear, United Kingdom.
How to identify it
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; Model/Catalog Number: R54544-12-SG; UDI-DI: 050552709TF06DXY; Lot Code: 497012, 502660, 497561, 502780, 497763, 502978, 498069, 503202, 499335, 503384, 499541, 503406, 499903, 503536, 500405, 503733, 500630, 503900, 500706, 504179, 500812, 504397, 501030, 504628, 501615, 504822; Model/Catalog Number: R54544-18-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496899, 500956, 497076, 501169, 497584, 501188, 499227, 502430, 499417, 502951, 499461, 503306, 499897, 503430, 499898, 503529, 499899, 504180, 499908, 504543, 500407, 504823, 500477; Model/Catalog Number: R54544-18-SG; UDI-DI: 050552709TF06DXY; Lot Code: 496809, 501616, 497346, 501710, 497665, 502431, 498972, 503735, 499909, 503937, 500782, 504573, 501256, 504824; Model/Catalog Number: R54549-16-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496659, 497629, 496918, 499814, 497077, 500408; Model/Catalog Number: R54549-20-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496455, 499910, 496811, 500480, 496919, 501734, 497516, 503706, 499083, 504152;
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)