Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound Gel, 5 liters; NC70479-5/North Coast Ultrasound Gel, 5 liters; NC70479-5C/Norco Ultrasound Gel, 5 liters (4); NC70479-5C/North Coast Ultrasound Gel, 5 liters (4); NC70479C/Norco Ultrasound Gel, 250 mL (24); NC70479C/North Coast Ultrasound Gel, 250 mL (24)
- Company
- North Coast Medical Inc
- Recall Initiated
- August 27, 2021
- Recall Number
- Z-2582-2021
- Quantity
- 576
- Firm Location
- Morgan Hill, CA
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
Worldwide distribution. US nationwide, Canada, Israel, South Africa, Australia, South Korea, France, Singapore, Grand Cayman, and Switzerland
Lot / Code Info
All lots within the expiration date.
Root Cause
Process control
Action Taken
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 NCMRecall@ncmedical.com. 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)