Natus Medical recalls sterile drainage collection bags (REF: NT821732C) due to potential contamination from incomplete bioburden testing. Affected items sold with Rx only.
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Natus Medical is recalling sterile drainage collection bags that may not be properly sterilized due to incomplete testing. This could lead to infections if used in medical procedures.
The bags may not be properly sterilized because of incomplete bioburden testing. This could allow harmful bacteria to contaminate the drainage system during medical procedures.
Patients using prescription drainage systems with this specific bag model. Healthcare providers who use the bags for medical procedures are most at risk.
Check for the model reference NT821732C and the lot numbers listed in the UDI (00382830050562/1FX0004951658-1FX0005126475). These bags are prescription-only items.
Verify the model reference NT821732C and lot numbers listed in the UDI to confirm if your bag is affected.
The bags may not be properly sterilized due to incomplete bioburden testing, which could lead to contamination during medical procedures.
Check for the model reference NT821732C and lot numbers listed in the UDI (00382830050562/1FX0004951658-1FX0005126475). These bags are prescription-only items.
The recall does not specify a remedy, so contact Natus Medical directly for guidance on next steps.
We’ve drafted a message you can send Natus Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0634-2024 — Natus Medical Natus Medical Hello, I own a Natus Medical that is covered by recall Z-0634-2024 from Natus 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
