Recall Z-0835-2020— Polymer Technology Systems, Inc.

Name: FDA recall Z-0835-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-02

Class II · Terminated

Class II FDA medical device recall by Polymer Technology Systems, Inc., initiated 2019-12-02, terminated 2020-07-06. It names one FDA 510(k) clearance: K140068. Product: Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411. Reason: 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..

Recalling firm: Polymer Technology Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-12-02
Terminated: 2020-07-06
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K140068 — CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEMPolymer Technology Systems, Inc.·cleared 2015-05-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.