Recall Z-2427-2021— Philips North America LLC
Class II · Terminated
Class II FDA medical device recall by Philips North America LLC, initiated 2021-07-16, terminated 2023-05-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator. Reason: Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patient.
- Recalling firm
- Philips North America LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-16
- Terminated
- 2023-05-12
- Firm location
- Bothell, WA, United States
Product description
Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator
Reason for recall
Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patient
Data sourced from openFDA. This site is unofficial and independent of the FDA.