Recall Z-0330-2013 ยท HGP Electrode, Circular (Spiral), Scalp And Applicator
Vital Signs Devices, a GE Healthcare Company
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.
| Date | Nov 16, 2012 (initiated Oct 16, 2012) |
| Status | Terminated |
| Reason | Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing. |
| 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 h |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K792669 | COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE Ge Medical Systems Information Technologies, Feb 11, 1980 |