FDA-Device2020-01-29Class II
Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036
Polymer Technology Systems, Inc.
Hazard
One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
Sold states
The products were distributed US Nationwide. The products were distributed to the following foreign countries: Australia, Austria, Belgium, Bermuda, Canada, China, Chile, Costa Rica, Cayman Islands, Czech Republic, England, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Jordan, Lebanon, Lithuania, Mexico, Morocco, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Trinidad, UAE.
Affected count
44,448
Manufactured in
7736 Zionsville Rd, Indianapolis, IN, United States
Products
Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0834-2020Don't want to check this manually?
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