FDA Recall Open, Classified

EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208

Recall: Z-2583-2021 · Initiated August 27, 2021

Recall

Recall Number: Z-2583-2021
Event Number: 88613
Firm: North Coast Medical Inc
FEI Number: 1000124207
Product Code: ITX
Status: Open, Classified
Root Cause: Process control
Initiated: August 27, 2021
Address: 780 Jarvis Dr, Ste 100, Morgan Hill, CA, 95037-2885

Description

Reason

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

On 08/17/2021, an online posting went live informing customers to discontinue use of affected products. On 08/27/21, recall notices were mailed to customers. Customers were asked to do the following: 1) Immediately examine your inventory and discontinue use, quarantine, and stop distribution of all affected gels and lotions manufactured by Eco-Med Pharmaceutical. 2) If affected product has been further distributed, notify customers, and forward the recall notification down to the user level. If you have any questions concerning this communication, please don t hesitate to contact [email protected]. 3) Complete and return the Recall Acknowledgment and Disposal Form via email/mail. A contact telephone number was also provided: 800-821-9319, Monday thru Friday 6:00AM-4:00PM (PST)

Distribution

Worldwide distribution. US nationwide, Canada, Israel, South Africa, Australia, South Korea, France, Singapore, Grand Cayman, and Switzerland

Quantity