Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A… — Class II medical device recall Z-0330-2013
Terminated recall by Vital Signs Devices, a GE Healthcare Company, reported 2012-11-28, distributed nationwide. Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number
| Recall number | Z-0330-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vital Signs Devices, a GE Healthcare Company, Totowa, NJ, United States |
| Recall initiated | 2012-10-16 |
| Classified | 2012-11-16 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2014-04-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Reason classes | packaging |
| Lot numbers | S03123 |
| Model numbers | 7000AA0, 7000AA0A |
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 for recall
Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0330-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.