EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
- Company
- Red Medical Supplies
- Recall Initiated
- August 11, 2021
- Recall Number
- Z-0089-2022
- Quantity
- 2000
- Firm Location
- Vancouver Canada
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.
Distribution
Firm sold product through Amazon.com. Domestic distribution nationwide.
Lot / Code Info
All product manufactured by Eco-Med between 2020.09.23 - 2021.08.08
Root Cause
Process control
Action Taken
According to the firm, Amazon.com has issued recall notification to all customers via email. Customers were instructed to return the product as soon as possible. An automatic refund has been issued by Amazon.com as soon as the product was recalled. Amazon.com is in charge of the disposal.