Philips recall: Labeling Error
Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01)…
Why was Philips recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Lot Y111220-01
- 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)…
- Recalling firm
- Philips North America LLC
- Quantity
- 19,840 units
- 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
- Recall date
- September 15, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)