3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 electrodes per card; 4 cards per pouch; 20 pouches per shipper box (800 electrodes total).
FDA Recall Z-0421-2021 · Posted None
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Recalling Firm3M Company - Health Care Business
Recall StatusTerminated
Product CodeDRX
Date Initiated2020-09-15
Date Terminated2022-02-01
Product Quantity287,200 units
Reason for Recall
Corrosion could cause performance failures in the product.
Firm Action
The recalling firm issued customer letters to consignees on 10/7-8/2020. The recalling firm is requesting a returned acknowledgement form from the consignee. Distributors will also be sent a template customer letter and customer acknowledgement so that they may notify their customers.
The recalling firm will initiate multiple attempts to follow up with non responders.
Customers and distributors are requested to dispose of any products still in their possession.
Root Cause
Process control
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Europe (Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Sweden) and Worldwide (China, Taiwan, Singapore, Indonesia, Japan, Mexico, Peru, Costa Rica, Canada).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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