| Product: |
Physio-Control Inc., LIFEPAK CR Plus Automated External Defibrillator (AED)
Only the Physio-Control LIFEPAK CR PLUS AEDs with the serial numbers below are affected by this recall.
Serial Numbers
37026963, 37026983, 37026984, 37026997, 37027002
37027008, 37027039, 37027040, 37027049, 37027053
37027063, 37027065, 37027066, 37027070, 37027071
37027073, 37027075, 37027090, 37027099, 37027105
37027122, 37027197, 37027529, 37027569, 37031393
37037850, 37037893, 37037986, 37038002, 37038211
37038365, 37135986, 37154526, 37154638
The serial number is located on the underside of the device.
The AEDs were manufactured and distributed from July 9, 2008 through August 19, 2008.
|
| FDA Comments: |
Physio-Control called their customers from August 18-19, 2009 with a follow-up email message on August 20, 2009. The company sent replacements on August 19, 2009.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.
|