Medical Device Recall: Z-0029-2022

FDA Recalls dataset · Firm: Aesthetics Systems Usa Inc · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2021-08-23 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0029-2022.

Recall Res Number
Z-0029-2022
Recalling Firm / Manufacturer
Aesthetics Systems Usa Inc
FEI Number
3006482872
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2021-08-23
Date Posted
N/A
Date Terminated
N/A
Product Code
ITX
Event Number
88624
Product Quantity
23
Product Description Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
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.
Action Details 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.
Distribution Pattern U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.
Code Information / Serial Numbers All lots with valid expiration dates

Related Establishments / Registrations

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