FDA-Device2012-11-28Class II
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.
Vital Signs Devices, a GE Healthcare Company
Hazard
Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing.
Sold states
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.
Affected count
126 cases (50 pouches per case)
Manufactured in
20 Campus Rd, N/A, Totowa, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0330-2013Don't want to check this manually?
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