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PYRAMES INC
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for PYRAMES INC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-04-09FDA-DeviceClass IIBoppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
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.
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