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U.S. Department of Health and Human Services

Class 1 Device Recall EcoGel 200 RED Medical Supplies Clear Ultrasound Gel

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 Class 1 Device Recall EcoGel 200 RED Medical Supplies Clear Ultrasound Gelsee related information
Date Initiated by FirmAugust 11, 2021
Create DateOctober 14, 2021
Recall Status1 Open3, Classified
Recall NumberZ-0089-2022
Recall Event ID 88726
510(K)NumberK955246 
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
ProductEcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
Code Information All product manufactured by Eco-Med between 2020.09.23 - 2021.08.08
Recalling Firm/
Manufacturer		 Red Medical Supplies
1037 Broadway W Unit 101
Vancouver Canada
Manufacturer Reason
for Recall		Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
FDA Determined
Cause 2		Process control
ActionAccording to the firm, Amazon.com has issued recall notification to all customers via email. Customers were instructed to return the product as soon as possible. An automatic refund has been issued by Amazon.com as soon as the product was recalled. Amazon.com is in charge of the disposal.
Quantity in Commerce2000
DistributionFirm sold product through Amazon.com. Domestic distribution nationwide.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = ITX
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