Z-0067-2022 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 20, 2021
- Initiation Date
- August 24, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25103 units
Product Description
ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs
Reason for Recall
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of RI, AL, AR, AZ, CA, CO, CT, FL, GA, GU, HI, IA, IL, IN, KS, KY, MA, MD, LA, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA and the countries of Canada and Nova Scotia.
Code Information
All lots for the following distributed product codes: Product Code: ECO 85CB - ECO 85CB Lotion Ultrasound 8.5 oz 24/cs Product Code: ECO 40JBC - ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs Product Code: ECO 40JMC - ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs Product Code: NDC P301008 - NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs Product Code: NDC P301105 - NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs Product Code: NDC P301115 - NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs Product Code ECO 30GS - ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl Product Code: ECO 30GB - ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs