Home / Recalls / Polymer Technology Systems, Inc. / Z-0834-2020

Z-0834-2020 Class II Terminated

Recalled by Polymer Technology Systems, Inc. — Indianapolis, IN

FDA device recall Z-0834-2020 was initiated by Polymer Technology Systems, Inc. on December 2, 2019 and is designated Class II. 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 … The recall status is terminated (terminated July 6, 2020). Affected quantity: 44,448.

Recall Details

Product Type: Devices
Report Date: January 29, 2020
Initiation Date: December 2, 2019
Termination Date: July 6, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 44,448

Product Description

Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036

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 Pattern

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.

Code Information

All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00304040040539

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