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U.S. Department of Health and Human Services

Class 2 Device Recall Corometrics Qwik Connect Plus Spiral Electrode

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  Class 2 Device Recall Corometrics Qwik Connect Plus Spiral Electrode see related information
Date Initiated by Firm October 16, 2012
Date Posted November 16, 2012
Recall Status1 Terminated 3 on April 16, 2014
Recall Number Z-0330-2013
Recall Event ID 63481
510(K)Number K792669  
Product Classification Electrode, circular (spiral), scalp and applicator - Product Code HGP
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.
Code Information Lot #S03123 Model #7000AA0 
Recalling Firm/
Manufacturer		 Vital Signs Devices, a GE Healthcare Company
20 Campus Rd
Totowa NJ 07512-1210
For Additional Information Contact Ms. Gwen Braeger
262-548-2608
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HGP and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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