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FDA-Device2025-12-24Class IIMISBRANDING

Rocket 18Fg Seldinger Catheter Procedure Tray recalled for improper securing labeling

Rocket Medical
LABEL MIX UPCOCTILMAMENHNJNMOHRISCTX

Stop using Rocket chest tube tray R54544-18-PK

The instruction manual and labeling for the Rocket 18Fg Seldinger Catheter Procedure Tray contain misleading information that may cause the chest tube to be secured incorrectly. This could result in the tube falling out during use.

  • Stop using affected units immediately if you have model R54544-18-PK with the lot codes listed in the recall notice.
  • Contact Rocket Medical Plc for corrected labeling or replacement units.
  • Review the lot number on your device packaging to determine if it is affected.
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
630 units
Manufactured in
Industrial Estate Sedling Road Wear Industrial Estate, Washington, Tyne & Wear, United Kingdom
Products
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-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-0952-2026

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