FDA recall Z-2427-2021

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 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

Distribution

Worldwide distribution. US Nationwide, Australia, Austria, Bolivia, Canada, Chile, China, Denmark, France, French Polynesia, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Republic of Korea, Malta, Martinique, Mexico, Monaco, Netherlands, Norway, Poland, Spain, Switzerland, Taiwan, United Kingdom, and Uruguay

Key facts

Status

Terminated

Initiation date

2021-07-16

Report date

2021-09-15

Termination date

2023-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bothell, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2427-2021