Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036
Check against the official notice below — it lists the full affected range.
Polymer Technology Systems, Inc. is recalling 44,448 units of the Henry Schein CardioChek Starter Kit (Reference Number 4060 HS, UDI: 00304040040539) distributed nationwide in the US and internationally across numerous countries including Canada, Australia, China, Mexico, and many others. The recall affects all units with serial numbers shipped between November 1, 2016 and October 25, 2019. The hazard involves certain batteries with a small dimensional difference in the negative button terminal that, when inserted incorrectly, can cause the battery terminals to make reverse contact, potentially leading to device overheating.
The source document does not specify a remedy or corrective action for consumers who have this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: 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 A Quantity: 44,448 Lot/code info: All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00304040040539
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.