PYRAMES INC: Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US distribution to states of: MA and CA Quantity: 35 Lot/code info: Software version: 2.2.3 Part/UFI-DI/Lot: 54-0002/10860007282925/24020902, 24040302, 23103002; 51-0007/10860007282901/24011702, 24111301

UPC codes

10860007282925, 10860007282901

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.