Device 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.
Z-0330-2013
Product summary
- Event
- Event 63481
- Status
- Terminated
- Classification
- Class II
- Quantity
- 126 cases (50 pouches per case)
- Official record key
device-enforcement:Z-0330-2013
Official wording
Reason: Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing.
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.
Derived failure modes
-
Labeling or packaging
incomplete package