FDA Device Recall Z-0068-2022

National Distribution & Contracting Inc · La Vergne, TN

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl

Lot / serial / GTIN: All lots for the following distributed product code: Product Code: ECO 50TS - ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser

Quantity: 3 units

Reason for recall

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.

Recall record

Recall number: Z-0068-2022
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: 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.
Recall initiated: 2021-08-24
Classified by FDA Center: 2021-10-13
FDA published: 2021-10-20
Recalling firm: National Distribution & Contracting Inc
Firm location: La Vergne, TN

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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