Home / Recalls / Vital Signs Devices, a GE Healthcare Company / Z-0330-2013

Z-0330-2013 Class II Terminated

Recalled by Vital Signs Devices, a GE Healthcare Company — Totowa, NJ

Recall Details

Product Type: Devices
Report Date: November 28, 2012
Initiation Date: October 16, 2012
Termination Date: April 16, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 126 cases (50 pouches per case)

Product Description

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.

Reason for Recall

Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing.

Distribution Pattern

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.

Code Information

Lot #S03123 Model #7000AA0