Recall Z-0951-2026
Rocket Medical Plc · initiated November 7, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Model/Catalog Number: R54544-12-SG; UDI-DI: 050552709TF06DXY; Lot Code: 497012, 502660, 497561, 502780, 497763, 502978, 498069, 503202, 499335, 503384, 499541, 503406, 499903, 503536, 500405, 503733, 500630, 503900, 500706, 504179, 500812, 504397, 501030, 504628, 501615, 504822;
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.
FDA-determined cause: Labeling design
Action taken
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.
Details
- Recall number
- Z-0951-2026
- Initiated
- November 7, 2025
- Posted by FDA
- December 18, 2025
- Product code
- GBX – Catheter, Irrigation
- Quantity
- 240 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
- Recalling firm
- Rocket Medical Plc
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0950-2026 Class II | Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray…IFU and device kit labeling contains misleading statements leading to improper securing of the device… | 11/07/2025Open, Classified |
| Z-0952-2026 Class II | Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray…IFU and device kit labeling contains misleading statements leading to improper securing of the device… | 11/07/2025Open, Classified |
| Z-0953-2026 Class II | Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard…IFU and device kit labeling contains misleading statements leading to improper securing of the device… | 11/07/2025Open, Classified |
| Z-0954-2026 Class II | Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray…IFU and device kit labeling contains misleading statements leading to improper securing of the device… | 11/07/2025Open, Classified |
| Z-0955-2026 Class II | Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray…IFU and device kit labeling contains misleading statements leading to improper securing of the device… | 11/07/2025Open, Classified |