Reported May 8, 2019 · Terminated
Fetal Spiral Electrode, Model No. 9898 031 37631
Philips North America, LLC
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: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Fetal Spiral Electrode, Model No. 9898 031 37631
- Lot codes and dates
- All products currently in distribution.
- Amount recalled
- 1,971,925 (78,877 boxes)
Where it was sold
- Nationwide
Why it was recalled
During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.
This product could cause temporary or reversible health problems — stop using it.
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