Z-0955-2026 Class II Ongoing
FDA device recall Z-0955-2026 was initiated by Rocket Medical Plc on November 7, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 246 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 24, 2025
- Initiation Date
- November 7, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 246 units
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.
Distribution Pattern
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
Code Information
Model/Catalog Number: R54549-20-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496455, 499910, 496811, 500480, 496919, 501734, 497516, 503706, 499083, 504152;