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FDA-Device2025-12-24Class IIMISBRANDING

Rocket 16Fg Seldinger chest tube recalled for improper securing risk

Rocket Medical
LABEL MIX UPCOCTILMAMENHNJNMOHRISCTX

Stop using Rocket chest tube (Model R54549-16-PK)

Rocket Medical's 16Fg Seldinger chest tube procedure tray has misleading instructions that may cause the device to be secured improperly and fall out during use. The affected product is model R54549-16-PK from specific lot codes (496659, 497629, 496918, 499814, 497077, 500408).

  • Stop using the device immediately if you have one of the affected lot codes
  • Review the product labeling for correct securing procedures
  • Contact Rocket Medical or your healthcare provider for guidance on replacement or corrective measures
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
840 units
Manufactured in
Industrial Estate Sedling Road Wear Industrial Estate, Washington, Tyne & Wear, United Kingdom
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0954-2026

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