Rocket Medical recalls 18Fg Seldinger Catheters with Safety Guard (model R54544-18-SG) due to potential to fall out if not secured properly. Affected units have 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 18Fg Seldinger Catheters with Safety Guard (model R54544-18-SG) because their labeling may lead to improper securing, increasing the risk of the device falling out during use. This could cause injury if the catheter dislodges unexpectedly.
The device's labeling contains misleading statements that could cause it to become improperly secured. If not properly anchored, the catheter might fall out during medical procedures, potentially causing injury.
Healthcare professionals using the catheter for chest tube procedures are most at risk. Patients receiving the catheter during medical treatment may also be affected.
Check for the model number R54544-18-SG on the catheter packaging. Affected units have specific lot codes: 496809, 501616, 497346, 501710, 497665, 502431, 498972, 503735, 499909, 503937, 500782, 504573, 501256, 504824.
Review the product packaging for the model number R54544-18-SG and lot codes listed above.
If you have the recalled catheter, secure it correctly following the updated instructions to prevent dislodgement.
The model number is R54544-18-SG.
Affected lot codes include 496809, 501616, 497346, 501710, 497665, 502431, 498972, 503735, 499909, 503937, 500782, 504573, 501256, 504824.
The labeling contains misleading statements that could lead to improper securing, increasing the risk of the catheter falling out during use.
We’ve drafted a message you can send Rocket Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0953-2026 — Rocket Medical Rocket Medical Hello, I own a Rocket Medical that is covered by recall Z-0953-2026 from Rocket Medical. 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.
