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FDA-Device2025-12-24Class IIMISBRANDING

Rocket 18Fg Seldinger Catheter recalled for misleading labeling that may cause device displacement

Rocket Medical
LABEL MIX UPCOCTILMAMENHNJNMOHRISCTX

Stop using Rocket chest tube model R54544-18-SG

Rocket Medical's 18Fg Seldinger Catheter with Safety Guard (model R54544-18-SG) has misleading instructions on how to properly secure the device. This labeling error can lead to improper placement, causing the chest tube to fall out during use. The recall affects 110 units distributed across multiple U.S. states and international locations.

  • Stop using the affected chest tube immediately if you have one with lot codes 496809, 501616, 497346, 501710, 497665, 502431, 498972, 503735, 499909, 503937, 500782, 504573, 501256, or 504824.
  • Contact your healthcare provider or hospital to report the product and receive guidance on replacement.
  • Check any procedures performed with this device for potential complications.
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
110 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 with Safety Guard Model/Catalog Number: R54544-18-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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0953-2026

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