Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Sof
Summary
The FDA issued a Class II for Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray by Rocket Medical Plc. Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during us.
Details
Source
Device Recall
External ID
Z-0952-2026
Action Date
2025-12-24
Status
Ongoing
Category
device
Product Description
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-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
Lot/Code Info: Model/Catalog Number: R54544-18-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496899, 500956, 497076, 501169, 497584, 501188, 499227, 502430, 499417, 502951, 499461, 503306, 499897, 503430, 499898, 503529, 499899, 504180, 499908, 504543, 500407, 504823, 500477;
Quantity Affected: 630 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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-07
Company
Tyne & Wear
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 208 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Rocket Medical Plc has 7 FDA actions in our database, including 6 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Rocket Medical Plc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Rocket Medical Plc have FDA actions?
Rocket Medical Plc has 7 FDA actions in our database, including 6 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0952-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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