FDAFDA · Food and drugs·Recall number Z-0187-2018
LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 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.
Published December 20, 2017 · Recall initiated: October 27, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Physio-Control, Inc.
- Distributor
- 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.
- Lot
- 45932237, 46042286, 45979590, 46050960, 45979954, 46052545, 46007867, 46061770, 46023185, 46063054, 46023823, 46078012,
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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