The Recall Desk
HighFDA (Devices)·Z-1174-2018·Announced 2018-04-04

ConMed Mini Infant Radiotranslucent Electrodes Recalled for Adhesive Defect

ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on contact wires may impede conductivity and cause device 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 involves a risk-of-harm product (medical device for infants) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed adverse events.

Plain-English summary

ConMed Corporation is recalling 18,720 units of the Mini Infant Radiotranslucent Electrode (REF/Catalog Number 2602). 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 covers specific lot numbers distributed worldwide, including the United States, New Zealand, Saudi Arabia, Switzerland, the United Arab Emirates, Uruguay, and the Republic of Macedonia.

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 electrode. The source text does not report any specific injuries or illnesses associated with this defect.

Healthcare facilities and distributors should stop using the affected lots and contact ConMed Corporation for instructions on return or replacement. Consumers should not use these electrodes if they are unsure of the lot number and should consult their healthcare provider for appropriate alternatives.

The recalled product

Product
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 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
Manufacturer
ConMed Corporation
Category
Medical Device — Cardiac Electrodes
Hazard
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: Y011813-09
  • Y040612-16
  • Y061214-15
  • Y090712-04
  • Y012714-08
  • Y040715-02
  • Y06291501
  • Y091914-07
  • Y013012-04
  • Y04291601
  • Y072012-14
  • Y100412-08
  • Y020713-13
  • Y050313-10
  • Y072513-04
  • Y103114-03
  • Y022814-09
  • Y050412-08
  • Y07291601
  • Y110912-12

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.

See all 5 products in this recall →

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