Madison Polymeric Engineering recalls EP-4 Flexible Endoscope Pre-Clean Kits due to potential microbial contamination exceeding safety limits. Affected lots may not meet required hygiene standards for medical use.
Affected lots may have exceeded its microbial limits.
Madison Poly:4 Flexible Endoscope Pre-Clean Kits (EP-4) are being recalled because some batches may have microbial levels that exceed safety standards. This could lead to inadequate cleaning of medical instruments, potentially increasing infection risks during procedures.
The kits may contain microbial levels above safe limits, meaning they might not effectively remove contaminants from medical instruments. This could lead to inadequate cleaning and increase infection risks during procedures.
Healthcare facilities using the EP-4 kits for endoscope pre-cleaning are most at risk. Patients and staff could face infection risks if the kits fail to properly clean instruments.
Check for the EP-4 model number on the product label. Affected lots include EP-4 with expiration codes EXP20 l 7 l 209A, EXP20 l 80512A, and EP-4D lot EXP20 l80520A.
Look for the EP-4 model number and expiration codes on the product label to determine if it's affected.
The recall is due to potential microbial levels exceeding safety limits in some batches, which could lead to inadequate cleaning of medical instruments.
The official recall notice does not specify a remedy for affected kits, so contact Madison Polymeric Engineering directly for guidance.
Check the product label for EP-4 model with expiration codes EXP20 l 7 l 209A, EXP20 l 80512A, or EP-4D lot EXP20 l80520A.
We’ve drafted a message you can send Madison Polymeric Engineering to request your refund or repair — edit it as you like.
Subject: Recall Z-1182-2018 — Madison Polymeric Engineering Madison Polymeric Engineering Hello, I own a Madison Polymeric Engineering that is covered by recall Z-1182-2018 from Madison Polymeric Engineering. 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.
