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U.S. Department of Health and Human Services

Class 1 Device Recall UltraMyossage

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 Class 1 Device Recall UltraMyossagesee related information
Date Initiated by FirmSeptember 07, 2021
Create DateOctober 05, 2021
Recall Status1 Open3, Classified
Recall NumberZ-0010-2022
Recall Event ID 88623
510(K)NumberK962840 
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
ProductUltra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Code Information All Lots manufactured by Eco-Med Pharmaceutical, Inc
Recalling Firm/
Manufacturer		 DJO, LLC
5919 Sea Otter Pl Ste 200
Carlsbad CA 92010-6750
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 09/03/21, recall notices were mailed and emailed to customers. Customers were asked to take the following action: a) Immediately remove and destroy the gel products located in the DJO, LLC / DJO FRANCE kits that contain the affected product. Follow all local/state or country regulations for disposal b) Immediately stop use of ALL ultrasound gels and lotions labeled manufactured by Eco-Med Pharmaceutical (regardless of lot). c) In addition, if you have further distributed this product, please identify your customers, and notify them at once of this product recall by sharing this recall notification letter. d) DJO, LLC / DJO FRANCE has partnered with Stericycle/Sedgwick as our vigilance partner. Please complete the attached Return Response and return to DJOglobalrecall@sedgwick.com. The following website is provided: djoglobal.com
Quantity in Commerce8,702
DistributionWorldwide distribution - U.S. Nationwide distribution including in the states of ND, NJ, CO, HI, CA, MA, FL, GA, IN, WA, NY, TX, IA, TN, NV, LA, CT, VA, NC, WI, MS, OR, MI, AL, MN, VT, IL, OH, AR, NM, DE, PA, SC, AZ, MD, RI, KY, UT, MO, OK, MT, ID, NE, WY, ME, WV, SD, KS, PR, NH, DC, AK, VI and the countries of France, China, Mexico, Ontario, Australia.
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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