Z-2427-2021 Class II Terminated
FDA device recall Z-2427-2021 was initiated by Philips North America LLC on July 16, 2021 and is designated Class II. 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 The recall status is terminated (terminated May 12, 2023). Affected quantity: 19,840 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 15, 2021
- Initiation Date
- July 16, 2021
- Termination Date
- May 12, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,840 units
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
Distribution Pattern
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
Code Information
Lot Y111220-01