Recall Z-0954-2026— Rocket Medical Plc
Class II · Ongoing
Class II FDA medical device recall by Rocket Medical Plc, initiated 2025-11-07. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use..
- Recalling firm
- Rocket Medical Plc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-11-07
- Firm location
- Tyne & Wear, United Kingdom
Product 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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.