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U.S. Department of Health and Human Services

Class 1 Device Recall LiquaSonic Ultrasound Gel 250mL

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  Class 1 Device Recall LiquaSonic Ultrasound Gel 250mL see related information
Date Initiated by Firm August 20, 2021
Create Date September 09, 2021
Recall Status1 Open3, Classified
Recall Number Z-2391-2021
Recall Event ID 88540
510(K)Number K955246  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product LiquaSonic Ultrasound Gel 250mL, Model No. 001205
Code Information UDI 00856589006120, All lot codes. Product will be discontinued and will not be reintroduced.
Recalling Firm/
Manufacturer
Athena Medical Products Inc
11270 Groome Rd St # B
Cincinnati OH 45242
For Additional Information Contact Athena Recall Coordinator
888-216-7307
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 August 20, 2021, the firm issued an Urgent Medical Device Recall letter to its only customer, who is a distributor. The letter explained the product issue and asked that the distributor identify their customers and notify them at once of the product recall. ALL lots of product should be returned or destroyed. Athena will no longer purchase or distribute products manufactured by Eco-Med. If you or your customers have any questions you can call the Recall Coordinator at 888-216-7307 or email athena8649@stericycle.com.
Quantity in Commerce 12,240 cases of 12
Distribution Distributed to one distributor within the US.
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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