{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "186149", "product_res_number": "Z-1375-2021", "event_date_initiated": "2021-03-24", "event_date_created": "2021-04-19", "recall_status": "Open, Classified", "res_event_number": "87483", "product_code": "FRN", "k_numbers": [ "K133532" ], "product_description": "Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)", "code_info": "Serial Numbers of devices serviced/purchased 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"firm_fei_number": "3007409280", "recalling_firm": "Pacific Medical Group Inc.", "address_1": "212 Avenida Fabricante", "city": "San Clemente", "state": "CA", "postal_code": "92672-7538", "additional_info_contact": "800-449-5328", "reason_for_recall": "Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, within infusion pump modules. Over time, the posts on the front bezel component may crack or separate. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.", "root_cause_description": "Component design/selection", "action": "On 03/24/2021, Medical Device Recall Notifications were emailed to customers. Customers were asked to take the following actions:\n\nIf you have affected product, remove these devices from clinical use and immediately quarantine them until the impacted parts can be returned to the recalling firm; contact Customer Service 800-449-5328, pm.recallapm@avantehs.com. The recall part number is RCL2021-823-01. Once returned, the affected device will be evaluated and inspected and where the component under recall is identified, it will be replaced by our organization with the OEM component and then returned. If your facility has used the component under recall in repairs of the top assembly immediately stop use and quarantine the affected product until the impacted parts are replaced. If you have resold/distributed the affected product, please forward this notice to your customers. Complete and submit the recall acknowledgment form to pm.recallapm@avantehs.com", "product_quantity": "2452", "distribution_pattern": "Distribution US nationwide.", "openfda": { "k_number": [ "K912589", "K900467", "K123822", "K830177", "K781171", "K883653", "K813562", "K915407", "K832167", "K930459", "K083689", "K141102", "K896075", "K900888", "K072105", "K905610", "K141389", "K790814", "K875347", "K864138", "K990259", "K890457", "K921050", "K844792", "K041714", "K902835", "K950419", "K050433", "K242660", "K880857", "K953896", "K111275", "K832410", "K921072", "K980378", "K023491", "K931549", "K952799", "K820219", "K782020", "K811774", "K905713", "K830605", "K910758", "K214045", "K860086", "K925449", "K842479", "K910934", "K925091", "K914589", "K981776", "K760370", "K943952", "K821661", "K944351", "K875348", "K802820", "K800629", "K910844", "K921073", "K813473", "K831258", "K950766", "K002126", "K843615", "K023189", "K882047", "K895644", "K855215", "K883609", "K850669", "K230041", 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