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Accelerated Care Plus Corporation Recall 88602

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

Accelerated Care Plus Corporation Recall 88602 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2518-2021
Event ID88602
Event DescriptionOmnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
Product TypeDevices
DistributionUS nationwide distribution.
Quantity9436
Recall ReasonUltrasound 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
Device Classification20211006
Device Code InfoDistributed from January 1, 2018 thru August 4, 2021
Center Classification Date20210924
Recall Initiation Date20210825
Recalling FirmAccelerated Care Plus Corporation
Initial Notification Letter
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