Z-0330-2013Class II

Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and...

Name: Z-0330-2013 Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and...
Creator: Vital Signs Devices, a GE Healthcare Company
Published: 2012-10-16
License: https://open.fda.gov/license/

Vital Signs, Inc. / initiated 2012-10-16 / Terminated / root cause: manufacturing process

FDA source

Vital Signs Devices, a GE Healthcare Company began a recall of Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal... on 2012-10-16. FDA classified it as Class II and gives the reason as "Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0330-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-16
Posted: 2012-11-16
Terminated: 2014-04-16
Recalling firm: Vital Signs, Inc.
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.
Product code: HGP Electrode, Circular (Spiral), Scalp And Applicator
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter on October 16, 2012 via Fed Ex to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: DO NOT use Qwik Connect Plus Spiral Electrodes part number 7000AAO with lot number S03123 or product with missing lot numbers; isolate all affected product; complete and return the Urgent Medical Device Correction Confirmation form via fax at 800-535-7923, return form even if no recall product is in inventory; to return only unused product, and if they have forwarded any affected lot numbers of this product to any other healthcare institutions, forward a copy of this letter to those institutions. If you have any questions or concerns regarding this notification, contact GEMSIT Customer Service at +1-800-588-7044 (Domestic) or Vital Signs Customer Service at +1-800-932-0760 (International). Hours of operation: 8:00 am EST to 6:00 pm EST.
Quantity in commerce: 126 cases (50 pouches per case)
Distribution: 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.
Product codes and lots: Lot #S03123 Model #7000AA0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0330-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0330-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16

Product code HGP

K792669Class IICorometrics-Push Button Spiral ElectrodeGe Medical Systems Information Technologies / cleared 1980-02-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)