Vital Signs Devices, a GE Healthcare Company: Medical Device Recall in 2012 - (Recall #: Z-0330-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 16, 2012

Date Posted: November 28, 2012

Recall Number: Z-0330-2013

Event ID: 63481

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.

Status: Terminated

Product Quantity: 126 cases (50 pouches per case)

Code Information:

Lot #S03123 Model #7000AA0

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.

Voluntary or Mandated:

Voluntary: Firm initiated