Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0834-2020 — Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036

U.S. FDA — Device Enforcement · United States · 2019-12-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0834-2020
Date of alert
2019-12-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Polymer Technology Systems, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00304040040539
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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