[pending] Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Numbe
Pending LLM rewrite. Source: FDA_DEVICE Z-0955-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
The recalled product
- Product
- 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 w
- Manufacturer
- Rocket Medical Plc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Model/Catalog Number: R54549-20-PK
- UDI-DI: 050552709TF06DXY
- Lot Code: 496455
- 499910
- 496811
- 500480
- 496919
- 501734
- 497516
- 503706
- 499083
- 504152
Distribution
Distributed in 12 states:
- CO
- CT
- IL
- MA
- ME
- NH
- NJ
- NM
- OH
- RI
- SC
- TX
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