Z-0330-2013 Class II Terminated
FDA device recall Z-0330-2013 was initiated by Vital Signs Devices, a GE Healthcare Company on October 16, 2012 and is designated Class II. 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. The recall status is terminated (terminated April 16, 2014). Affected quantity: 126 cases (50 pouches per case).
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