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Philips North America LLC recalls Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE
Recalled September 15, 2021 · FDA recall Z-2427-2021 · Philips North America
Hazard
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 · FDA Class II
Units
19,840 units
Sold at
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
Description
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
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
Manufacturer(s)
Philips North America LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →