Recall Z-0089-2022 ยท ITX Transducer, Ultrasonic, Diagnostic
Red Medical Supplies
EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
| Date | Aug 11, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| 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. |
| Quantity | 2000 |
| Distribution | Firm sold product through Amazon.com. Domestic distribution nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955246 | ECOGEL 200 ULTRASOUND GEL Eco-Med Pharmaceuticals, Inc., Feb 21, 1996 |