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Recall Observatory FDA recall evidence

Device product

Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 5 electrodes per card; 1 card per pouch; 200 pouches per shipper box (1000 electrodes total).

Z-0419-2021

September 15, 2020

Class II

Product summary

Firm
3M Company - Health Care Business
Event
Event 86519
Status
Terminated
Classification
Class II
Quantity
1,572,000 units
Official record key
device-enforcement:Z-0419-2021

Official wording

Reason: Corrosion could cause performance failures in the product.

Code information: Cat. No. V2560-5 (SKU: 70-2011-8381-4, SAP #: 7100205978). GTIN: 10707387788176 (pouch) and 50707387788174 (shipper) Lots: 202112EQ (Expiration 2021-12-09); 202201EA (Expiration 2022-01-01); 202205EH (Expiration 2022-05-14); and 202205EI (Expiration 2022-05-19)

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.