FDA-Device2025-12-24Class IIMISBRANDING
Rocket 12Fg Seldinger Catheter with Safety Guard recalled for mislabeling risk of dislodgement
Stop using Rocket chest tube model R54544-12-SG
Rocket Medical's 12Fg Seldinger Catheter chest tubes have misleading instructions that may lead to improper securing of the device. This increases the risk that the catheter could fall out during use. The FDA has identified 240 units across multiple lot codes distributed in the US and internationally.
- Stop using affected Rocket chest tubes (model R54544-12-SG, lot codes 497012–504822)
- Contact your healthcare facility or Rocket Medical for guidance on safe removal and replacement
- Review the corrected labeling and instructions before using any remaining stock
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.
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
240 units
Manufactured in
Industrial Estate Sedling Road Wear Industrial Estate, Washington, Tyne & Wear, United Kingdom
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0951-2026Don't want to check this manually?
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