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U.S. Department of Health and Human Services

Class 2 Device Recall Rocket

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 Class 2 Device Recall Rocketsee related information
Date Initiated by FirmNovember 07, 2025
Date PostedDecember 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0951-2026
Recall Event ID 97994
Product Classification Catheter, irrigation - Product Code GBX
ProductBrand 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
Code Information 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;
FEI Number 3002808026
Recalling Firm/
Manufacturer		 Rocket Medical Plc
Industrial Estate Sedling Road Wear Industrial Estate
Washington
Tyne & Wear United Kingdom
Manufacturer 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.
FDA Determined
Cause 2		Labeling design
ActionOn 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 Commerce240 units
DistributionDomestic: 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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