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U.S. Department of Health and Human Services

Class 1 Device Recall Ecogel 200 Ultrasound gel (Action De Gala, FuSion Conductive Gel)

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  Class 1 Device Recall Ecogel 200 Ultrasound gel (Action De Gala, FuSion Conductive Gel) see related information
Date Initiated by Firm August 23, 2021
Create Date October 06, 2021
Recall Status1 Open3, Classified
Recall Number Z-0029-2022
Recall Event ID 88624
510(K)Number K955246  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Code Information All lots with valid expiration dates
Recalling Firm/
Manufacturer
Aesthetics Systems Usa Inc
1149 Pomona Rd Ste J
Corona CA 92882-7600
For Additional Information Contact
714-550-9980
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
Action On 08/23/2021, recall notices were emailed to customers. Customer were asked to take the following actions: Stop using and discard affected product. If you have further distributed affected product, please notify them at once of this product recall by sharing the recall notification letter. Complete the response form indicating the product and lot numbers identified and the actions taken in the comment section. Customers with questions are encouraged to call the recalling firm at 1-800-332-8763.
Quantity in Commerce 23
Distribution U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.
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 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) Database 510(K)s with Product Code = ITX and Original Applicant = ECO-MED PHARMACEUTICALS, INC.
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