ConMed Mini Infant Radiotranslucent Electrodes Recalled for Adhesive Conductivity Issues
ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on contact wires may impede conductivity and cause failure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect could cause failure during critical procedures (pacing/defibrillation), representing a risk of harm where injury has not yet been reported.
Plain-English summary
ConMed Corporation is recalling 18,720 units of the Mini Infant < 3KG, Radiotranslucent Electrode, Philips Plug Style Connector (REF/Catalog Number 2602H). These non-sterile, disposable devices are indicated for use in external pacing, defibrillation, and monitoring applications for pediatric infants weighing less than 10 kg (22 lbs.).
The recall was initiated because wire sets of certain devices were assembled with adhesive on the contact wires. This adhesive may impede conductivity and could cause failure of the device. The affected lots are Y01221601, Y03241702, Y10121501, Y020713-17, Y04071501, and Y12021501.
The devices were distributed worldwide, including nationwide in the United States and in New Zealand, Saudi Arabia, Switzerland, the United Arab Emirates, Uruguay, and the Republic of Macedonia. Healthcare providers and facilities should stop using the affected devices and contact ConMed Corporation for further instructions.
The recalled product
- Product
- MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602…
- Manufacturer
- ConMed Corporation
- Affected units
- 18,720
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot Numbers: Y01221601
- Y03241702
- Y10121501
- Y020713-17
- Y04071501
- & Y12021501.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by ConMed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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