FDAClass IINovember 28, 2012

Corometrics Qwik Connect Plus Spiral Electrode recall

Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a…

Why was Corometrics Qwik Connect Plus Spiral Electrode recalled?

Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #S03123 Model #7000AA0

Product
Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a…
Recalling firm
Vital Signs Devices, a GE Healthcare Company
Quantity
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.
Recall date
November 28, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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