Rocket Medical Plc: Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/

Company / brand

Rocket Medical Plc

Product

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

Reason / 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.

Classification

Class II

Status

Ongoing

Distribution / sold at

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

Recall initiated

2025-11-07

Code info

Model/Catalog Number: R54544-12-SG; UDI-DI: 050552709TF06DXY; Lot Code: 497012, 502660, 497561, 502780, 497763, 502978, 498069, 503202, 499335, 503384, 499541, 503406, 499903, 503536, 500405, 503733, 500630, 503900, 500706, 504179, 500812, 504397, 501030, 504628, 501615, 504822;

Product quantity

240 units

Voluntary mandated

Voluntary: Firm initiated

City

Tyne & Wear

Country

United Kingdom

Event id

97994

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