3M Red Dot Monitoring Electrode Recall Due to Corrosion Risk
3M is recalling Red Dot Monitoring Electrodes because corrosion could cause performance failures in the ECG monitoring product.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of performance failure in a medical device, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
3M Company - Health Care Business is recalling 3M Red Dot Monitoring Electrodes with 4mm Adapter. The recall is due to a risk that corrosion could cause performance failures in the product.
The affected product is intended to be used by healthcare professionals for ECG monitoring. The recall involves 287,200 units distributed worldwide, including the United States, Europe, and various other countries.
Healthcare professionals should stop using the affected electrodes and contact 3M for further instructions.
The recalled product
- 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).
- Manufacturer
- 3M Company - Health Care Business
- Category
- Medical Device — ECG Electrodes
- Affected units
- 287,200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- 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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by 3M Company - Health Care Business under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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