Recall Z-2480-2021 ยท ITX Transducer, Ultrasonic, Diagnostic
AMTEC SALES Inc
EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used exte
| Date | Aug 12, 2021 |
| Status | Open, Classified |
| Reason | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. |
| Root cause | Process control |
| Action | The firm, Amtec/Print Media, issued a "URGENT: MEDICAL DEVICE RECALL - EXPANSION" notification letter to all impacted customers. This letter will be sent via email and includes a form that each customer is required to complete to indicate the recall information has been received and understood. The customers were also requested to do the following: 1. Please identify, quarantine, and destroy the product at your location; and provide a signed affidavit acknowledging its destruction. Please return this information via email to service@printmedia-inc.com or contact us for other return methods. |
| Quantity | 34,586 each |
| Distribution | Worldwide Distribution to US (nationwide) states of - FL, TX, OH, MD, PA, WA, CO, PR, VA, KY, OK, and CA; and OUS (international) to countries of - Honduras, Dominican Republic, El Salvador, Guatemala, Panama, and Costa Rica. |
| FDA record | Open on fda.gov |