Reported Feb 19, 2020 · Ongoing
Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced with the following
Pacific Medical Group Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pacific Medical Group Inc. · 212 Avenida Fabricante · San Clemente, CA · 92672-7538
Is this the product you have?
Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced with the following
4 of 4 products
| # | Product as published |
|---|---|
| 1 | Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310 |
| 2 | Pacific Medical GE Corometrics Nautilus TOCO Bottom Case, NFCM9315 |
| 3 | Pacific Medical GE Corometrics Nautilus TOCO Cable Assembly, NFCM9320 |
| 4 | Pacific Medical GE Corometrics Nautilus TOCO Coil with Screws, NFCM9325 |
- Lot codes and dates
- All serial numbers serviced between 1/19/15 and 4/2/19
- Amount recalled
- 10911
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was recalled
Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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