FDA-Device2025-12-24Class IIMISBRANDING
Rocket 20Fg Seldinger chest tube recalled for misleading securing instructions
What this means
Rocket Medical's 20Fg Seldinger chest tube procedure tray has misleading instructions that may prevent proper securing of the device. This could cause the tube to fall out during use. The issue affects 246 units distributed across multiple U.S. states and internationally.
- Stop using affected Rocket 20Fg chest tubes (Model R54549-20-PK, specific lot codes: 496455, 499910, 496811, 500480, 496919, 501734, 497516, 503706, 499083, 504152)
- Contact your healthcare facility or Rocket Medical for guidance on affected inventory
- Review proper securing procedures with your team before using any remaining stock
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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
Affected count
246 units
Manufactured in
Industrial Estate Sedling Road Wear Industrial Estate, Washington, Tyne & Wear, United Kingdom
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0955-2026Want us to check the next one for you?
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