Fetal Spiral Electrode recall
Fetal Spiral Electrode, Model No. 9898 031 37631
Why was Fetal Spiral Electrode 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.
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?
All products currently in distribution.
- Product
- Fetal Spiral Electrode, Model No. 9898 031 37631
- Recalling firm
- Philips North America, LLC
- Quantity
- 1,971,925 (78,877 boxes)
- Distribution
- Distributed nationwide within US. Worldwide international distribution.
- Recall date
- May 8, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)