{ "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": "2026-04-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Minneapolis", "state": "MN", "country": "United States", "classification": "Class I", "openfda": {}, "product_type": "Devices", "event_id": "69020", "recalling_firm": "CareFusion 203, Inc.", "address_1": "17400 Medina Rd Ste 100", "address_2": "N/A", "postal_code": "55447-1341", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Nationwide Distribution including AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MI, MN, MS,M0, NE, NV,NH,NH, NY NMC, OH, OR,PA, RID, SC, TN, TX, UT VT, VA, WA, and WI.", "recall_number": "Z-2593-2014", "product_description": "CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.", "product_quantity": "1729", "reason_for_recall": "CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The input port on the ventilators must have the adapters correctly aligned to function properly. Incorrect alignment may cause the pins in the connector to bend, causing the PTV AC power adapter and/or PTV Auto Lighter Power Cord to be shortened, and pre", "recall_initiation_date": "20140808", "center_classification_date": "20140919", "termination_date": "20151007", "report_date": "20141001", "code_info": "SERIAL # ENVE CUSTOMER UNITS: 26562 44554 44559 45317 45322 45324 45328 45330 45333 45334 45336 45339 45341 45343 45736 45737 45740 45741 45742 45744 45745 45750 45751 45752 45907 45908 46040 46041 46043 46044 46050 46051 46632 46636 46641 46642 46643 46644 46645 46646 47069 47071 47073 47075 47076 47077 47078 47079 47080 47081 47082 47210 47211 47213 47214 47215 47216 47217 47219 47221 47223 47225 47226 47227 47229 47230 47231 47232 47233 47234 47236 47237 47238 47239 47538 47539 47541 47542 47543 47544 47545 47546 47547 47548 47549 47550 47551 47552 47553 47554 47555 47556 47557 47558 47559 47560 47561 47562 47563 47564 47565 47566 47567 48759 48760 48761 48762 48763 48764 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