FDA Device Recall Z-0090-2022

Red Medical Supplies · Vancouver, N/A

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU

Lot / serial / GTIN: All product manufactured by Eco-Med between 2020.09.23 - 2021.08.08

Quantity: 639

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-0090-2022
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: N/A
Distribution: Firm sold product through Amazon.com. Domestic distribution nationwide.
Recall initiated: 2021-08-11
Classified by FDA Center: 2021-10-13
FDA published: 2021-10-20
Recalling firm: Red Medical Supplies
Firm location: Vancouver, N/A, Canada

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.

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