FDAFDA · Food and drugs·Recall number Z-0330-2013
Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.
Published November 28, 2012 · Recall initiated: October 16, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Vital Signs Devices, a GE Healthcare Company
- Distributor
- Worldwide distribution: USA (nationwide) including states: AZ, CA, CT, FL, GA, IL, KS, KY, MA, MD, MN, MO, NJ, NM, NY, OH, PA, SC,TX, WA, and WY; and countries of: Australia and Canada.
- Lot
- Lot #S03123 Model #7000AA0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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