FDA Device recall Z-0421-2021
3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 el…
- FDA Device
- Class II
- terminated
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class II recall of 3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 el… by 3m Health Care Business, citing corrosion could cause performance failures in the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0421-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-15 |
| Published | 2020-11-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | 3m Health Care Business |
| Distribution | US |
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).
Reason
Corrosion could cause performance failures in the product.
Identifiers
| code_info | Cat. No. 2228BA (SKU: CH-0000-1642-8, SAP #: 7000032072). GTIN: 10707387582200 (pouch); 50707387786996 (shipper) Lo…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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0421-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.