|
Class 1 Device Recall UltraMyossage |
|
Date Initiated by Firm |
September 07, 2021 |
Create Date |
October 05, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0010-2022 |
Recall Event ID |
88623 |
510(K)Number |
K962840
|
Product Classification |
Transducer, ultrasonic, diagnostic - Product Code ITX
|
Product |
Ultra-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 |
Action |
On 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 Commerce |
8,702 |
Distribution |
Worldwide 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 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.
|
|
|
|