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 provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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, Y03151701, Y050814-15, Y08031702, Y11131501, Y031715-11, Y05251701, Y081314-03, Y112414-03, Y032513-16, Y06071601, Y08231601, Y121613-07 Y03271501, Y060812-04, Y090514-11 & Y12181501.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- ConMed Corporation
- Reason for Recall:
- Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
Product Codes/Lot Numbers:
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, Y03151701, Y050814-15, Y08031702, Y11131501, Y031715-11, Y05251701, Y081314-03, Y112414-03, Y032513-16, Y06071601, Y08231601, Y121613-07 Y03271501, Y060812-04, Y090514-11 & Y12181501.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1174-2018
Related Recalls
Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used.
Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used
Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used