Boppli: Bedside Device Kit recall
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Why was Boppli: Bedside Device Kit 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Software version: 2.2.3 Part/UFI-DI/Lot: 54-0002/10860007282925/24020902, 24040302, 23103002; 51-0007/10860007282901/24011702, 24111301
- Product
- Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
- Recalling firm
- PYRAMES INC
- Quantity
- 35
- Distribution
- US distribution to states of: MA and CA
- Recall date
- April 9, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)