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Physio-Control, Inc. recalls LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are use
Recalled December 20, 2017 · FDA recall Z-0186-2018 · Physio-Control
Hazard
The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols. · FDA Class I
Units
14,219 units in total
Sold at
Worldwide distribution: US (nationwide) including Puerto Rico and Guam and countries of: Canada, Austria, Belgium, Czech Republic; Denmark, Finland, France, French Polynesia, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Australia, China, Hong Kong, Japan, Argentina, Mexico, Norway, Panama, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, and New Zealand.
Description
The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.
Product
LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.
Manufacturer(s)
Physio-Control, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →