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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2518-2021 |
| Event ID | 88602 |
| Event 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. |
| Product Type | Devices |
| Distribution | US nationwide distribution. |
| Quantity | 9436 |
| Recall 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 |
| Device Classification | 20211006 |
| Device Code Info | Distributed from January 1, 2018 thru August 4, 2021 |
| Center Classification Date | 20210924 |
| Recall Initiation Date | 20210825 |
| Recalling Firm | Accelerated Care Plus Corporation |
| Initial Notification | Letter |
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