{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "191726", "product_res_number": "Z-0727-2022", "event_date_initiated": "2022-01-31", "event_date_created": "2022-03-07", "recall_status": "Terminated", "event_date_terminated": "2024-04-29", "res_event_number": "89487", "product_code": "LHI", "k_numbers": [ "K925401", "K942988" ], "product_description": "Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 \nDispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.", "code_info": "Product Code 412005 Lot Number 0061788969 Expiration date 5/31/2026 \nGUDID 04022495769633", "firm_fei_number": "2523676", "recalling_firm": "B. Braun Medical, Inc.", "address_1": "901 Marcon Blvd", "city": "Allentown", "state": "PA", "postal_code": "18109-9512", "additional_info_contact": "Jonathan Severino\n833-426-1464", "reason_for_recall": "This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace the device or may cause contamination of the fluid path that can lead to bloodstream infection.", "root_cause_description": "Under Investigation by firm", "action": "On January 31, 2022, the firm distributed Urgent Medical Device Recall Notification letters to customers. \n\nIf you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the end user/customer level. \n\nDetermine your current inventory of the affected lots within your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. Record the total number of individual units (within partial cases) and the number of full-unopened cases on the Product Removal Acknowledgement form. If you have no inventory remaining, please enter zero (0) on the form. Return the completed Product Removal Acknowledgement form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to PA_QualityAssurance.BBMUS_Service@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). A BBMI Customer Support Representative provide instructions for handling the affected product and arrange for return to BBMI. This may include credit or replacement product.", "product_quantity": "15,550 ea (US); 900 ea (OUS)", "distribution_pattern": "US Nationwide distribution in the states of AZ, CA, FL, LA, MI, MO, MS, NC, NJ, OH, PA, TN, TX, and UT. The country of Canada.", "openfda": { "k_number": [ "K101940", "K231071", "K902853", "K090917", "K120384", "K220856", "K955594", "K110023", "K172631", "K183187", "K970789", "K260301", "K041564", "K850757", "K960466", "K842345", "K974198", "K201415", "K060866", "K852467", "K972117", "K923782", "K973654", "K853212", "K890204", "K860595", "K013087", "K250345", "K890205", "K963583", "K140730", "K921031", "K854008", "K150787", "K092318", "K900865", "K932462", "K213513", "K994323", "K896990", "K080174", "K964989", "K001831", "K132040", "K830836", "K853188", "K001368", "K853830", "K832347", "K121182", "K013523", "K070584", "K233284", "K961008", "K003730", "K151423", "K232055", "K852882", "K920015", "K243404", "K861434", "K090634", "K853075", "K043304", "K072511", "K970359", "K192154", "K024239", "K904225", "K182819", "K990711", "K230464", "K080976", "K093182", "K023747", "K903159", "K844904", "K926071", "K092782", "K041232", "K243985", "K240748", "K900585", "K200893", "K925401", "K173577", 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"device_name": "Set, I.V. Fluid Transfer", "medical_specialty_description": "General Hospital", "regulation_number": "880.5440", "device_class": "2" } } ] }