WhichRecall
Class IIReported 2025-12-24

Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-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

Recalled by Rocket Medical Plc

Reason for Recall

IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

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Recall Number
Z-0955-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-07
Reported
2025-12-24
Distribution
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
Code Info
Model/Catalog Number: R54549-20-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496455, 499910, 496811, 500480, 496919, 501734, 497516, 503706, 499083, 504152;
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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