ConMed Recalls Mini Infant Radiotranslucent Electrodes Due to Adhesive Defect
ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on the contact wires may impede conductivity and cause failure.
What this means for you
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 is classified as FDA Class II. The hazard involves a risk of device failure in a critical medical application (defibrillation/pacing) for infants, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ConMed Corporation is recalling 18,720 units of the Mini Infant Radiotranslucent Electrode, ZOLL Connector (REF/Catalog Number 2602Z). 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 defect may impede conductivity and could cause failure of the device. The affected units were distributed worldwide, including the United States (nationwide), New Zealand, Saudi Arabia, Switzerland, the United Arab Emirates, Uruguay, and the Republic of Macedonia.
Healthcare providers and consumers should stop using the affected electrodes and contact ConMed Corporation for instructions on return or replacement. The recall covers specific lot numbers listed in the official FDA notice.
The recalled product
- Product
- MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the
- 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 (20)
- Lot Numbers: Y010713-02
- Y03181603
- Y051414-08
- Y072012-12
- Y09301601
- Y012312-14
- Y03201511
- Y05151513
- Y07251703
- Y100314-14
- Y013114-16
- Y032513-17
- Y052313-10
- Y07271507
- Y10061701
- Y02151602
- Y03251604
- Y06011502
- Y07271702
- Y10071603
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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