PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: December 24, 2025 Initiated: November 7, 2025 #Z-0955-2026

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

Reason for Recall

IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

Details

Recalling Firm
Rocket Medical Plc
Units Affected
246 units
Distribution
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
Location
Tyne & Wear

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Rocket Medical Plc. Units affected: 246 units.
Why was this product recalled? ▼
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 24, 2025. Severity: Moderate. Recall number: Z-0955-2026.

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