The Recall Desk
ModerateFDA (Devices)·Z-1189-2021·Announced 2021-03-17

Physio-Control Recalls LIFEPAK CR2 Defibrillators Due to Missing Lid Magnets

Physio-Control is recalling 89,763 LIFEPAK CR2 defibrillators because missing lid magnets may cause premature battery depletion.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (battery depletion) without reported injuries or deaths, fitting the criteria for a moderate severity rating.

Plain-English summary

Physio-Control, Inc. is recalling 89,763 units of the LIFEPAK CR2 defibrillator (Model 3321605-xxx). The recall is due to complaints that some units have missing lid magnets, which may result in premature battery depletion.

The affected devices are distributed worldwide, including across the United States and in numerous international markets. The LIFEPAK CR2 is a fully automatic defibrillator designed for indoor and outdoor use in stationary environments, indicated for patients one year of age or older in cardiopulmonary arrest.

Consumers and healthcare facilities should check their device serial numbers against the list provided by the manufacturer or the FDA to determine if their unit is affected. If a unit is affected, users should contact Physio-Control for instructions on repair or replacement.

The recalled product

Product
PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is det
Manufacturer
Physio-Control, Inc.
Category
Medical Device — Defibrillator
Hazard
Affected units
89,763

Is your product affected?

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

Lot numbers (11)

  • Model Number 3321605-xxx
  • U.S. Device Part Numbers with Conforming Lids: CR2-2-001281
  • CR2-2-001279
  • CR2-2-001285
  • CR2-2-001278
  • CR2-2-001283
  • CR2-2-001280
  • CR2-2-001451
  • CR2-2-001452
  • CR2-2-000396
  • CR2-2-001457

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically:

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