Z-0951-2026Class II

Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number...

Name: Z-0951-2026 Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number...
Creator: Rocket Medical Plc
Published: 2025-11-07
License: https://open.fda.gov/license/

Rocket Medical / initiated 2025-11-07 / Open, Classified / root cause: labeling and UDI

FDA source

Rocket Medical Plc began a recall of Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description... on 2025-11-07. FDA classified it as Class II and gives the reason as "IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0951-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-07
Posted: 2025-12-18
Recalling firm: Rocket Medical
Product: Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG 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
Product code: GBX Catheter, Irrigation
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
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.
Quantity in commerce: 240 units
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
Product codes and lots: Model/Catalog Number: R54544-12-SG; UDI-DI: 050552709TF06DXY; Lot Code: 497012, 502660, 497561, 502780, 497763, 502978, 498069, 503202, 499335, 503384, 499541, 503406, 499903, 503536, 500405, 503733, 500630, 503900, 500706, 504179, 500812, 504397, 501030, 504628, 501615, 504822;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0951-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0950-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0951-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0952-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0953-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0954-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0955-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18

Product code GBX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)