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Open, Classified

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)

FDA Recall Z-2582-2021 · Posted None

Recall StatusOpen, Classified
Product CodeITX
Date Initiated2021-08-27
Product Quantity576

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

Firm 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)

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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