FDAFebruary 24, 2025device
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
pyrames
UPCs
1086000728292510860007282901
Recall history
No related federal recalls on record for this brand yet.
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