Henry Schein recalls CardioChek Starter Kit (ref 4060 HS) from Nov 2016 to Oct 2019 due to battery insertion risk causing overheating. Affected units have specific serial numbers.
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.
Henry Schein is recalling CardioChek Starter Kits made between November 2016 and October 2019 because some batteries can overheat if inserted incorrectly. This could lead to potential fire or injury if the battery terminals make reverse contact.
The batteries have a small dimensional difference in the negative button terminal. When inserted incorrectly, this can cause reverse contact between battery terminals, potentially leading to overheating.
Users of the CardioChek Starter Kit with serial numbers from November 2016 to October 2019. Medical device users are most at risk if they have the affected batteries.
Check if your CardioChek Starter Kit has a serial number in the range shipped from November 1, 2016 to October 25, 2019. The unique device identifier (UDI) is 00304040040539.
Verify your CardioChek Starter Kit's serial number was shipped between November 1, 2016 and October 25, 2019.
The batteries have a small dimensional difference in the negative button terminal that can cause reverse contact when inserted incorrectly, potentially leading to overheating.
Check if your CardioChek Starter Kit was shipped between November 1, 2016 and October 25, 2019 using the unique device identifier (UDI) 00304040040539.
The recall record does not specify a remedy, so you should contact Henry Schein directly for guidance.
We’ve drafted a message you can send Henry Schein to request your refund or repair — edit it as you like.
Subject: Recall Z-0834-2020 — Henry Schein Henry Schein Hello, I own a Henry Schein that is covered by recall Z-0834-2020 from Henry Schein. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
