FDA Device Recall Z-0067-2022

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 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

Lot / serial / GTIN: 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

Quantity: 25103 units

Reason for recall

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

Recall record

Recall number: Z-0067-2022
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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