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.
Reported: December 20, 2017 Initiated: October 27, 2017 #Z-0187-2018
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Physio-Control, Inc.
- Units Affected
- 14,219 units in total
- Distribution
- 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.
- Location
- Redmond, WA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Physio-Control, Inc.. Units affected: 14,219 units in total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 20, 2017. Severity: Critical. Recall number: Z-0187-2018.
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