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U.S. Department of Health and Human Services

Class 2 Device Recall 3M Red Dot

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  Class 2 Device Recall 3M Red Dot see related information
Date Initiated by Firm October 06, 2021
Create Date November 01, 2021
Recall Status1 Terminated 3 on January 17, 2024
Recall Number Z-0188-2022
Recall Event ID 88763
Product Classification Electrode, electrocardiograph - Product Code DRX
Product 3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box.

The 3M Red Dot Radiolucent Monitoring Electrode with Foam Tape 2244 is intended to be used by healthcare professionals for ECG monitoring. This electrode is disposable, intended for single use, and has been tested for up to 3 days wear.
Code Information Lot #202302LK, Exp. 2023-02-19, pouch UDI (01)1070738789449(17)230219(11)202302LK, shipper box UDI (01)50707387789447(17)230219(11)202302LK  Lot #202302LL, Exp. 2023-02-22, pouch UDI (01)1070738789449(17)230222(11)202302LL, shipper box UDI (01)50707387789447(17)230222(11)202302LL;  Lot #202302LM, Exp. 2023-02-22, pouch UDI (01)1070738789449(17)230222(11)202302LM, shipper box UDI (01)50707387789447(17)230222(11)202302LM;  Lot #202302LN, Exp. 2023-02-23. pouch UDI (01)1070738789449(17)230223(11)202302LN, shipper box UDI (01)50707387789447(17)230223(11)202302LN.
Recalling Firm/
Manufacturer		 3M Company - Health Care Business
3m Center 2510 Conway Ave
Bldg 275-5W-06
Saint Paul MN 55144-0001
For Additional Information Contact Ms. Janna Fischer
651-403-9356
Manufacturer Reason
for Recall		 Potential for breakage of the ECG electrode carbon stud from the eyelet.
FDA Determined
Cause 2		 Process control
Action The recalling firm, 3M Company, issued "Urgent - Medical Device Recall" letters dated 29 September 2021 to the distributors on 10/6/2021. The letter informs them of the issue and instructs them to immediately discontinue distribution of the affected lots and determine if any are in inventory. The affected product is to be destroyed by the distributor. The distributor is to notify any customers who have purchased the affected lots by using the enclosed Customer Letter and Customer Acknowledgment Form provided. The enclosed customer letter to be sent to the distributor's customers is dated 29 September 2021 and informs the customer of the issue. The customer is instructed to screen their facility or other storage locations to ensure all affected lots of the product are identified. They are to immediately cease use of affected lots of product and quarantine it for destruction/disposal. The customer is requested to pass the notification along to all who need to be aware within their organization or to any department where the affected product was transferred.Complete the attached Customer Acknowledgement Form with the following: o Acknowledge that you have read and understood this letter, whether or not you have any affected lots of the 3M" Red Dot" Radiolucent Monitoring Electrodes with Foam Tape, Catalog Number 2244 in stock at your facility; and o Indicate if you have any product in stock and dispose of this material per facility policy. o Email the completed form to 3MFieldSafetyAction@montage72.com. " Complete and return the Customer Acknowledgement Form to 3M even if your stock of affected lots of this product have been exhausted. " To request product replacement for affected lots requiring disposal, contact 3M Health Care Customer Helpline at 1-800-228-3957, option #7 or by email to 3MFieldSafetyAction@montage72.com. If you have questions regarding this matter, please contact your local 3M sales representative or the 3M Health Care Customer Hel
Quantity in Commerce 2,081,000 electrodes
Distribution US Nationwide Distribution to states of: AL, AZ, CA, IA, IL, LA, MD, MO, NC, NJ, and OH; and OUS Foreign distribution to countries of: Australia, Bermuda, Canada, China, France, Germany, Japan, the Netherlands, Singapore, Sweden, and Turkey.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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