Polymer Technology Systems Recalls CardioChek Starter Kits Due to Battery Overheating Risk
Polymer Technology Systems is recalling 44,448 Henry Schein CardioChek Starter Kits because a battery terminal defect can cause overheating if inserted incorrectly.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (overheating) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Polymer Technology Systems, Inc. is recalling 44,448 units of the Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036. The recall affects all serial numbers shipped between November 1, 2016, and October 25, 2019, with UDI 00304040040539. The products were distributed nationwide in the United States and to numerous foreign countries, including Australia, Canada, China, Germany, India, and the United Kingdom.
The recall is due to a small dimensional difference in the negative button terminal of one brand of batteries used in the device. If the batteries are inserted incorrectly, this difference can allow the battery terminals to make reverse contact. This reverse contact creates a potential for the batteries to overheat.
Consumers who possess these specific starter kits should stop using them immediately. They should contact Polymer Technology Systems, Inc. for instructions on how to return the product or obtain a replacement, as directed by the recall notice.
The recalled product
- Product
- Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036
- Manufacturer
- Polymer Technology Systems, Inc.
- Affected units
- 44,448
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Polymer Technology Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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