Reported Dec 24, 2025 · Ongoing
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG…
Rocket Medical PLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Rocket Medical Plc · Industrial Estate Sedling Road Wear Industrial Estate · Tyne & Wear · N/A
Is this the product you have?
- Brand NameRocket
- Product NameRocket 12Fg Seldinger Catheter
- with Safety Guard Model/Catalog NumberR54544-12-SG
- Software VersionN/A
- Product DescriptionChest 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
- ComponentN/A
- Lot codes and dates
- Model/Catalog NumberR54544-12-SG
- UDI-DI050552709TF06DXY
- Lot Code
497012502660497561502780497763502978498069503202499335503384499541503406499903503536500405503733500630503900500706504179500812504397501030504628501615504822
- Amount recalled
- 240 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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