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 externally only as a coupling medium for use in ultrasound procedures.
Recall
- Recall Number
- Z-2480-2021
- Event Number
- 88584
- Firm
- AMTEC SALES Inc
- FEI Number
- 3018301188
- Product Code
- ITX
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- August 12, 2021
- Address
- 1594 Nw 159th St, Miami, FL, 33169-5635
Description
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 externally only as a coupling medium for use in ultrasound procedures.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
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 [email protected] or contact us for other return methods. 2. Forward this notice to any accounts to whom you have further distributed the product. 3. Please use the following link to verify your receipt and understanding of the attached MEDICAL DEVICE RECALL EXPANSION notice/instructions, and provide quantity of products on hand. Please respond even if you do not have any affected product on hand, since this is our only way of ensuring that all customers have been adequately notified. https://lp.constantcontactpages.com/sv/jjwlFMb/urgentrecallnotice Customers must contact Print Media to confirm receipt of this notice and that they are proceeding with the recall via email, [email protected], to contact Print Media directly with questions, call (800) 994-3318, or (305) 884-0700.
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.
34,586 each