Rocket Medical Plc: Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Rocket Medical Plc
- Product
- 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
- 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: R54549-16-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496659, 497629, 496918, 499814, 497077, 500408;
- Product quantity
- 840 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Tyne & Wear
- Country
- United Kingdom
- Event id
- 97994
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