Rocket Medical recalls 12Fg Seldinger Catheter Procedure Tray (R54544-12-PK) due to labeling issues that may cause the tray to fall during medical procedures. Affected units include specific lot codes.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Rocket Medical is recalling its 12Fg Seldinger Catheter Procedure Tray (model R54544-12-PK) because the labeling might lead to improper securing, increasing the risk of the tray falling during use. This could cause injury to patients or healthcare workers.
The tray's labeling contains misleading statements that could result in it not being securely fastened. If the tray falls during medical procedures, it might cause injury to the patient or healthcare worker.
Healthcare professionals using the tray during chest tube procedures are most at risk. Patients receiving care with this device may also be affected if the tray falls.
Check for the model number R54544-12-PK on the tray. Affected units have specific lot codes: 496708, 501186, 496903, 501548, and other listed codes.
Look for the model number R54544-12-PK and associated lot codes to confirm if your tray is affected.
The labeling contains misleading statements that could lead to improper securing, increasing the risk of the tray falling during use.
Check the model number and lot codes to see if it's affected. If it is, contact Rocket Medical for guidance.
Yes, if the tray falls during use, it could cause injury to patients or healthcare workers.
We’ve drafted a message you can send Rocket to request your refund or repair — edit it as you like.
Subject: Recall Z-0950-2026 — Rocket Rocket Hello, I own a Rocket that is covered by recall Z-0950-2026 from Rocket. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
