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Open, Classified

EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU

FDA Recall Z-0089-2022 · Posted None

Recalling FirmRed Medical Supplies
Recall StatusOpen, Classified
Product CodeITX
Date Initiated2021-08-11
Product Quantity2000

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.

Firm Action

According to the firm, Amazon.com has issued recall notification to all customers via email. Customers were instructed to return the product as soon as possible. An automatic refund has been issued by Amazon.com as soon as the product was recalled. Amazon.com is in charge of the disposal.

Root Cause

Process control

Distribution Pattern

Firm sold product through Amazon.com. Domestic distribution nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K955246ECOGEL 200 ULTRASOUND GELEco-Med Pharmaceuticals, Inc. · 1996-02-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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