FDA-Device2025-12-24Class IIMISBRANDING
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK 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
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
635 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 Procedure Tray Model/Catalog Number: R54544-12-PK 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-0950-2026Want us to check the next one for you?
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