Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
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 Plus Professional Analyzer due to a battery issue. Certain batteries have a small dimensional difference in the negative button terminal that can allow them to be inserted incorrectly, potentially causing the battery terminals to make reverse contact and create a risk of overheating. The affected devices were distributed nationwide in the United States and to numerous countries including Canada, Mexico, Australia, China, and various European nations. The recall applies to all serial numbers shipped between November 1, 2016 and October 25, 2019.
The recall record does not specify a remedy or recommended course of 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 total Lot/code info: All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00304040037713
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.