Z-0068-2022 Class I Ongoing
FDA device recall Z-0068-2022 was initiated by National Distribution & Contracting Inc on August 24, 2021 and is designated Class I. Reason for recall: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. The recall status is ongoing. Affected quantity: 3 units.
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
- 3 units
Product Description
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
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 code: Product Code: ECO 50TS - ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser