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.
Enforcement
- Recall Number
- Z-0953-2026
- Event ID
- 97994
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Rocket Medical Plc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 24, 2025
- Initiation Date
- November 7, 2025
- Classification Date
- December 18, 2025
- Address
- Industrial Estate Sedling Road Wear Industrial Estate, Washington, Tyne & Wear, N/A, United Kingdom
Description
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.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
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;
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
110 units