FDA Device Recall Z-2582-2021
North Coast Medical Inc · Morgan Hill, CA
Class I — life-threatening Ongoing
Device
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)
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
Recall record
- Recall number
Z-2582-2021- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Worldwide distribution. US nationwide, Canada, Israel, South Africa, Australia, South Korea, France, Singapore, Grand Cayman, and Switzerland
- Recall initiated
- 2021-08-27
- Classified by FDA Center
- 2021-09-29
- FDA published
- 2021-10-06
- Recalling firm
- North Coast Medical Inc
- Firm location
- Morgan Hill, CA
Operational response
A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.
For the official FDA enforcement record, see FDA's Recall Search.