ConMed recalls Mini Infant <3kg Radiotranslucent Electrodes with adhesive on contact wires that may cause failure. Affected units have specific lot numbers. Stop using immediately.
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
ConMed is recalling Mini Infant <3kg radiotranslucent electrodes because adhesive on contact wires may impair conductivity and cause device failure. This could lead to improper medical monitoring or pacing in infants.
Adhesive on the contact wires may impede conductivity, causing the device to fail during medical monitoring or pacing. This could result in improper treatment or inadequate cardiac support for infants.
Parents or caregivers of infants under 10 kg (22 lbs) using these electrodes for medical monitoring or pacing. Infants with specific lot numbers are most at risk.
Check the lot number on the electrode packaging. Affected units include specific lot numbers: Y01221601, Y03241702, Y10121501, Y020713-17, Y04071501, and Y12021501.
Identify the lot number on the electrode packaging to determine if it is affected.
If the lot number matches the affected list, stop using the electrode immediately.
Adhesive on contact wires may impede conductivity, causing device failure during medical monitoring or pacing.
Lot numbers Y01221601, Y03241702, Y10121501, Y020713-17, Y04071501, and Y12021501.
No, affected units with adhesive on contact wires may cause device failure, so they should not be used.
We’ve drafted a message you can send ConMed to request your refund or repair — edit it as you like.
Subject: Recall Z-1175-2018 — ConMed ConMed Hello, I own a ConMed that is covered by recall Z-1175-2018 from ConMed. 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.
