{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "189148", "product_res_number": "Z-0067-2022", "event_date_initiated": "2021-08-24", "event_date_created": "2021-10-13", "recall_status": "Open, Classified", "res_event_number": "88640", "product_code": "ITX", "k_numbers": [ "K955246" ], "product_description": "ECO 85CB Lotion Ultrasound 8.5 oz 24/cs\nECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs\nECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs\nNDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs\nNDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs\nNDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs\nECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl\nECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs", "code_info": "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", "firm_fei_number": "2124637", "recalling_firm": "National Distribution & Contracting Inc", "address_1": "407 New Sanford Rd", "city": "La Vergne", "state": "TN", "postal_code": "37086-4184", "additional_info_contact": "615-366-3230", "reason_for_recall": "Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.", "root_cause_description": "Process control", "action": "Written recall notification notice titled, \"URGENT MEDICAL DEVICE RECALL\" was sent out to consignees via 2nd day air . The letter instructs the consignee to immediately stop using and discard products listed in the letter due to risk of bacterial contamination with Burkholderia cepacia complex (Bcc). The letter continues to state, \"1. Immediately destroy the all products manufactured by Eco-Med(we have included a certificate of destruction form with this letter): there are NDC private label products affected items P301008, P301105, and P301105 2. Forward this notice to any accounts to whom you have further distributed the product.\n3. Please complete the Request for Credit form pictures of product to be destroyed and the Certificate of Destruction form and return via email to compliance@ndc-inc.com for credit. Credit will only be issued for on hand product that a certificate of destruction for along with the credit request is received. Please respond even if you do not have any affected product on hand, since this our only way of ensuring that all customers have been adequately notified.\" Instructions specific to distributors are, \"Distributors must contact National Distribution & Contracting, Inc. to confirm receipt of this notice and that they are proceeding with the recall via email compliance@ndc-inc.com To contact National Distribution & Contracting, Inc. directly with questions email compliance@ndc-inc.com or call 615.366.3230 and ask for the compliance department. In addition, if you have further distributed this product, please identify your customers, and notify them at once of this product recall by sharing this recall notification letter. Please complete the form indicating the product and the lot numbers you have identified and actions taken in the comment section.\nYour Assistance is appreciated and necessary to prevent any consumer illness or harm.\" The letter mentions health professionals, consumers and patients can voluntarily report observed or", "product_quantity": "25103 units", "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.", "openfda": { "k_number": [ "K920307", "K912600", "K070515", "K012522", "K912364", "K943637", "K072164", "K221278", "K973958", "K992152", "K951723", "K081802", "K864812", "K853249", "K101816", "K844772", "K002193", "K040213", "K211969", "K153212", "K911115", "K992305", "K962093", "K944610", "K022860", "K962840", "K152403", "K982568", 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"device_name": "Transducer, Ultrasonic, Diagnostic", "medical_specialty_description": "Radiology", "regulation_number": "892.1570", "device_class": "2" } } ] }