Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
Class I - DangerousWhat Should You Do?
- Check if you have this product: All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00304040037713
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Polymer Technology Systems, Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
Product Codes/Lot Numbers:
All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00304040037713
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0835-2020
Related Recalls
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
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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.