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.
- Company
- Amtec Sales Inc
- Recall Initiated
- August 12, 2021
- Recall Number
- Z-2480-2021
- Quantity
- 34,586 each
- Firm Location
- Miami, FL
Reason for Recall
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
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.
Lot / Code Info
1) Ecogel 100 Imaging Gel, 250 mL bottle, Print Media Item Number 3541420 (12 each/pack; 72 each/case) 2) Ecogel 100 Imaging Gel, Set: 1 gal jug with 250mL dispenser, Print Media Item Number 3874672 (1 each/pack; 4 each/case) 3) Ecogel 200 Multipurpose Gel BLUE, 250mL bottle, Print Media Item Number 3113545 (12 each/pack, 72 each/case) 4) Ecogel 200 Multipurpose Gel BLUE, Set: 5L jug with 250mL dispenser, Print Media Item Number 1000033 (1 each/pack, 4 each/case) 5) Ecogel 200 Multipurpose Gel CLEAR, 250mL bottle, Print Media Item Number 3158655 (12 each/pack, 72 each/case) 6) Ecogel 200 Multipurpose Gel CLEAR, Set: 5L jug with 250mL dispenser, Print Media Item Number 7565432 (1 each/pack, 4 each/case) 7) Ecolotion Transmission Lotion, Set: 1 gal jug with 250mL dispenser, Print Media Item Number 6115004 (1 each/pack, 4 each/case)
Root Cause
Process control
Action Taken
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. 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, service@printmedia-inc.com, to contact Print Media directly with questions, call (800) 994-3318, or (305) 884-0700.