Infant and child defibrillator electrodes recalled over pediatric electrode delamination

Plain-English summary

Physio-Control, Inc. is recalling the Physio Control Infant/Child Reduced Energy Defibrillator Electrodes, catalogue numbers 11101-000016 and 11101-000017. The electrodes are pre-gelled, self-adhesive therapy electrodes allowing hands-free defibrillation, reducing delivered energy by a factor of 4:1, and are designed for trained personnel to defibrillate infants and children under 8 years old or weighing less than 25 kg. About 16,499 electrodes were distributed, 8,327 in the United States across 47 states and 8,172 outside it, to Australia, Canada, Hong Kong, Japan, Mexico, Malaysia, the Netherlands, New Zealand and Taiwan. The FDA has classified this recall as Class II.

The recall is due to pediatric defibrillator electrode delamination.

Affected product carries UDI-DI 00721902629013 and 00721902682483, across lots 315303, 315639, 315858, 316007, 320529 and 318931.

Facilities can identify affected electrodes by the catalogue number, UDI and lot numbers above, and may contact Physio-Control, Inc. for further information.

The recalled product

Product

PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, the

Manufacturer

Physio-Control, Inc.

Category

Medical Device — Defibrillation

Hazard

• electrode-delamination
• pediatric-device
• resuscitation-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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