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
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | November 07, 2025 |
| Reported | December 24, 2025 |
| Recalling firm | Rocket Medical Plc |
| Country / region | United Kingdom 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 |
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.
Product description
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
Affected products
- Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product Description:
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