Reported Apr 9, 2025 · Ongoing
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Pyrames 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: PYRAMES INC · 21730 Stevns Crk Blvd Ste 201a · Cupertino, CA · 95014-1171
Is this the product you have?
- BoppliBedside Device Kit
- REF54-0002; Sensor Band
- REF51-0007
- Lot codes and dates
2 of 2 products · 5 lot codes
Recalled lot codes, grouped by product number Part UFI-DI Lot 54-000210860007282925240209022404030223103002
51-0007108600072829012401170224111301
- Amount recalled
- 35
Where it was sold
Why it was recalled
Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 1) Ventilator lines not to touch the isolette (e.g. mattress, side rails, pillow) or patient, 2) Move affected monitor to patient's foot.
This product could cause temporary or reversible health problems — stop using it.
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