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
Enforcement
- Recall Number
- Z-0954-2026
- 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 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
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: R54549-16-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496659, 497629, 496918, 499814, 497077, 500408;
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
840 units