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Recall Observatory FDA recall evidence

Device product

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)

Z-2582-2021

August 27, 2021

Class I

Product summary

Firm
North Coast Medical Inc
Event
Event 88613
Status
Ongoing
Classification
Class I
Quantity
576
Official record key
device-enforcement:Z-2582-2021

Official wording

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

Code information: All lots within the expiration date.

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

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    bacterial contamination