FDAFDA · Food and drugs·Recall number Z-0954-2026
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
Published December 24, 2025 · Recall initiated: November 7, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Rocket Medical Plc
- Distributor
- 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
- Lot
- Model/Catalog Number: R54549-16-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496659, 497629, 496918, 499814, 497077, 500408;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.