Recall Z-0330-2013— Vital Signs Devices, a GE Healthcare Company

Name: FDA recall Z-0330-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-16

Class II · Terminated

Class II FDA medical device recall by Vital Signs Devices, a GE Healthcare Company, initiated 2012-10-16, terminated 2014-04-16. It names one FDA 510(k) clearance: K792669. 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.. Reason: Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing..

Recalling firm: Vital Signs Devices, a GE Healthcare Company
Classification: Class II
Status: Terminated
Initiated: 2012-10-16
Terminated: 2014-04-16
Firm location: Totowa, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K792669 — COROMETRICS-PUSH BUTTON SPIRAL ELECTRODEGe Medical Systems Information Technologies·cleared 1980-02-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.