Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall LiquaSonic Ultrasound Gel 250mL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall LiquaSonic Ultrasound Gel 250mLsee related information
Date Initiated by FirmAugust 20, 2021
Date PostedSeptember 09, 2021
Recall Status1 Terminated 3 on February 02, 2023
Recall NumberZ-2391-2021
Recall Event ID 88540
510(K)NumberK955246 
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
ProductLiquaSonic 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 ContactAthena 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
ActionOn 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 Commerce12,240 cases of 12
DistributionDistributed to one distributor within the US.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = ITX
-
-