Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Ca... – fall hazard (2025)
Misleading labeling may cause improper device placement, potentially increasing the risk of the device falling out.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK 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 Codes / Batch Numbers
Model/Catalog Number: R54544-12-PK, UDI-DI: 050552709TF06DXY, Lot Code: 496708, 501186, 496903, 501548, 497147, 502122, 497292, 502317, 497344, 502534, 497664, 502949, 499226, 503201, 499276, 503429, 499415, 503732, 499462, 503899, 499806, 503935, 499902, 504283, 500404, 504581, 500474, 504637, 500757, 504821, 500955, 505025
Products Sold
Model/Catalog Number: R54544-12-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496708, 501186, 496903, 501548, 497147, 502122, 497292, 502317, 497344, 502534, 497664, 502949, 499226, 503201, 499276, 503429, 499415, 503732, 499462, 503899, 499806, 503935, 499902, 504283, 500404, 504581, 500474, 504637, 500757, 504821, 500955, 505025;
A medical device manufacturer is recalling Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: due to IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during us. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, CT, IL, ME, MA, NH, NJ, NM, OH, RI, SC, TX
Page updated: Jan 10, 2026