Rocket Medical recalls 12Fg Seldinger catheters with safety guard due to misleading labeling that may cause device to fall out during use. Affected units have specific model numbers and 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 12Fg Seldinger catheters with safety guard because their labeling might lead to improper securing, increasing the risk of the device falling out during use. This could cause injury to the user.
The device's labeling contains misleading statements that could result in it not being secured properly. If the catheter falls out during use, it may cause injury to the user.
Healthcare professionals using the Rocket 12Fg Seldinger catheter with safety guard for chest tube procedures are most at risk. Patients receiving this device during medical procedures may also be affected.
Check for model number R54544-12-SG on the device. Affected units include specific lot codes: 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.
Look for model number R54544-12-SG on the catheter. If it matches, the device is affected.
The labeling may lead to improper securing, so it's not safe to use as described. Affected units should be checked for the model number and lot codes.
Check the model number and lot codes. If it matches the affected list, contact Rocket Medical for guidance.
Look for model number R54544-12-SG and check the lot codes listed in the recall notice.
We’ve drafted a message you can send Rocket to request your refund or repair — edit it as you like.
Subject: Recall Z-0951-2026 — Rocket Rocket Hello, I own a Rocket that is covered by recall Z-0951-2026 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.
