Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2549-2019.
The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the defibrillator An Infant/Child pad cartridge should not be used on an adult because it delivers lower energy (50 J vs 150 J) than the Adult pads cartridge and may therefore not be effective on an adult.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2549-2019.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2549-2019.
Philips North America LLC
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Philips North America Llc Recall FAQ
Philips North America Llc is the subject of a cardiac devices safety report: Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758. The notice was published on August 8, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 181,894 units are potentially affected.