Rocket Medical Plc — 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 manu
⚠️ IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Is this relevant to me?
- Geography
- CO, CT, IL, MA, ME, NH, NJ, NM, OH, RI, SC, TX
- Source agency
- FDA
- Category
- Health
- Published
- November 7, 2025
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
What's affected?
- 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
- Brand
- Rocket Medical Plc
- Lot code
- 497012
Additional details
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;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 240 units.
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