Mozarc Medical recalls 12 Fr/Ch catheter tray extensions due to potential packaging seal issues. Affected units may have compromised seal integrity.
A potential issue with the seal integrity of header bag packaging.
Mozarc Medical is recalling certain acute high pressure catheter tray extensions because the packaging seal might be compromised. This could lead to contamination or improper use of the medical device.
The packaging seal could be compromised, potentially allowing contamination or improper use of the catheter tray extensions. This might lead to infection or incorrect medical procedures if the device is not properly protected.
Healthcare professionals using the specific catheter tray extensions with the described model and lot numbers are affected. Patients receiving care through these devices may be at risk if the packaging seal fails.
Check for the model: 12 Fr/Ch (4.0 mm) x 24 cm, lot number 2427800166, and reference number 8888104004HP. The product was sold with specific UDI-DI numbers.
Verify the lot number 2427800166 and reference number 8888104004HP on the packaging.
The recall states a potential issue with packaging seal integrity, but it does not specify that the product causes serious injury or death. The risk is considered low.
Look for the model 12 Fr/Ch (4.0 mm) x 24 cm, lot number 2427800166, and reference number 8888104004HP on the packaging.
The recall does not specify a remedy, so no action is required beyond checking the product details.
We’ve drafted a message you can send Mozarc Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0426-2026 — Mozarc Medical Mozarc Medical Hello, I own a Mozarc Medical that is covered by recall Z-0426-2026 from Mozarc 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.
