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Recall Observatory FDA recall evidence

Device product

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).

Z-0421-2021

September 15, 2020

Class II

Product summary

Firm
3M Company - Health Care Business
Event
Event 86519
Status
Terminated
Classification
Class II
Quantity
287,200 units
Official record key
device-enforcement:Z-0421-2021

Official wording

Reason: Corrosion could cause performance failures in the product.

Code information: Cat. No. 2228BA (SKU: CH-0000-1642-8, SAP #: 7000032072). GTIN: 10707387582200 (pouch); 50707387786996 (shipper) Lots: 202204BA (Expiration 2020-04-20); 202204BB (Expiration 2020-04-22); 202204BC (Expiration 2020-04-27); 202204BD (Expiration 2020-04-28); 202204BE (Expiration 2020-04-29); 202204BF (Expiration 2020-04-30); 202204BG (Expiration 2020-05-04); 202204BH (Expiration 2020-05-05); 202204BI (Expiration 2020-05-07); 202204BJ (Expiration 2020-05-12); 202204BK (Expiration 2020-05-14); 202204BL (Expiration 2020-05-22); 202204BM (Expiration 2020-05-28); and 202204BN (Expiration 2020-06-02)

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).

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Corrosion could cause performance failures in the product.