Rocket Medical recalls fetal bladder drainage catheters model R57405 due to kinking risk and improper use for pleural drainage. Affected units have UDI 05055270913678.
A complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used. In addition, the company became aware that the device had been used for pleural drainage, which is not included in the device indications.
Rocket Medical is recalling fetal bladder drainage catheters model R57405 because they can kink before use, making them unusable. The device was also mistakenly used for pleural drainage, which it's not intended for. This could lead to improper treatment if used incorrectly.
The catheter can kink before use, preventing proper drainage and causing potential harm. It was also used for pleural drainage, which is not approved for this device, risking complications.
Healthcare providers using fetal bladder drainage catheters model R57405 are affected. Pregnant patients receiving this catheter are at risk if the device is kinked or misused.
Check for the model number R57405 on the catheter. Affected units have a unique device identifier (UDI) of 05055270913678.
Inspect the catheter for kinks before use; if kinked, do not use it.
Ensure the catheter is only used for fetal bladder drainage, not pleural drainage.
No, this catheter is only intended for fetal bladder drainage and not for pleural drainage.
Look for the model number R57405 and unique device identifier (UDI) 05055270913678.
Do not use the catheter if it is kinked.
We’ve drafted a message you can send Rocket Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0512-2020 — Rocket Medical Rocket Medical Hello, I own a Rocket Medical that is covered by recall Z-0512-2020 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.
