Rocket Medical Plc recalls Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Mod…

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

Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-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. Component: N/A

On November 12, 2025, Urgent Medical Device Correction Letters were sent to customers. Actions to be taken: 1. Ensure a copy of this letter and the updated IFU are available to all users or potential users of this device. 2. Complete the FSN acknowledgement form and return via the email provided.

• FDA enforcement recordOfficial FDA database entry for Z-0951-2026
• FDA device classification · GBXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4200The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Rocket Medical PlcSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.