Recall Z-2549-2019— Philips North America LLC

Name: FDA recall Z-2549-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-08

Class II · Terminated

Class II FDA medical device recall by Philips North America LLC, initiated 2018-08-08, terminated 2021-04-29. It names one FDA 510(k) clearance: K020715. Product: Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758. Reason: 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..

Recalling firm: Philips North America LLC
Classification: Class II
Status: Terminated
Initiated: 2018-08-08
Terminated: 2021-04-29
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K020715 — PHILIPS M5066A AND M5068APhilips Medical Systems·cleared 2002-11-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.