Home / Recalls / Medical Devices
Vital Signs Devices, a GE Healthcare Company recalls Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applic
Recalled November 28, 2012 · FDA recall Z-0330-2013 · Vital Signs Devices, a GE Healthcare
Hazard
Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing. · FDA Class II
Units
126 cases (50 pouches per case)
Sold at
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.
Description
Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing.
Product
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.
Manufacturer(s)
Vital Signs Devices, a GE Healthcare Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →