Rocket Medical Plc — 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 manufac
⚠️ IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Is this relevant to me?
- Geography
- CO, CT, IL, MA, ME, NH, NJ, NM, OH, RI, SC, TX
- Source agency
- FDA
- Category
- Health
- Published
- November 7, 2025
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
What's affected?
- Product
- 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
- Rocket Medical Plc
- Lot code
- 496659
Additional details
Model/Catalog Number: R54549-16-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496659, 497629, 496918, 499814, 497077, 500408;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 840 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.