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Open, Classified

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

FDA Recall Z-0954-2026 · Posted 2025-12-18

Recalling FirmRocket Medical Plc
Recall StatusOpen, Classified
Product CodeGBX
Date Initiated2025-11-07
Product Quantity840 units

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.

Firm Action

On November 12, 2025, Urgent Medical Device Correction Letters were sent to customers. Actions to be taken: 1. Ensure a copy of this letter and the updated IFU are available to all users or potential users of this device. 2. Complete the FSN acknowledgement form and return via the email provided.

Root Cause

Labeling design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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