Mozarc Medical recalls specific models of hemodialysis catheter sport packs due to potential breach of sterile packaging. Affected units may pose infection risks if used without proper sterilization.
Potential breach of sterile barrier packaging.
Mozarc Medical is recalling certain hemodialysis catheter sport packs because the sterile packaging might be compromised, increasing infection risk during medical procedures. This is serious for patients needing dialysis treatments.
The sterile packaging could be breached, allowing contaminants to enter the catheter. This might lead to infections during dialysis treatments if the catheter is not properly sterilized after the breach.
Patients using hemodialysis treatments with these specific catheter packs are most at risk. Healthcare providers who handle the equipment may also be affected if the packaging breach occurs.
Check for model numbers 8888123405P, 8888123411P, 8888128455P, 8888128461P, 8888119365P, 8888119371P, 8888133505P or UDI numbers starting with 20884521157788. The packs were sold with specific lot/serial numbers listed in the recall notice.
Inspect the sterile packaging for any signs of damage or breaches before use.
Reach out to Mozarc Medical for guidance on whether the specific model or lot number is affected.
The recall is for potential packaging breaches that could lead to infections if the catheter is not properly sterilized after a breach. The risk is serious but not immediate for all users.
Check the model numbers or UDI numbers listed in the recall notice. Affected units include specific model numbers and lot/serial numbers provided in the record.
No, but you should check the packaging for damage and contact Mozarc Medical to confirm if your specific unit is affected before use.
We’ve drafted a message you can send Mozarc Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1888-2025 — Mozarc Medical Mozarc Medical Hello, I own a Mozarc Medical that is covered by recall Z-1888-2025 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.
