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Recall Observatory FDA recall evidence

Device product

Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.

Z-2518-2021

August 25, 2021

Class I

Product summary

Firm
Accelerated Care Plus Corporation
Event
Event 88602
Status
Ongoing
Classification
Class I
Quantity
9436
Official record key
device-enforcement:Z-2518-2021

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: Distributed from January 1, 2018 thru August 4, 2021

Distribution pattern: US nationwide distribution.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    bacterial contamination