{ "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": "210306", "product_res_number": "Z-0283-2025", "event_date_initiated": "2024-09-24", "event_date_posted": "2024-11-01", "recall_status": "Open, Classified", "res_event_number": "95449", "product_code": "LHI", "k_numbers": [ "K201415" ], "product_description": "Brand Name: Vial2Bag Advanced\nProduct Name: Vial2Bag Advanced 20mm Admixture Device\nModel/Catalog Number: 6070030\nSoftware Version: Not applicable\nProduct Description: The Vial2Bag Advanced 20mm Admixture Device is a single use, fluid transfer device that allows for the reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is provided as a sterile, non-pyrogenic product. The device is intended to be used with standard drug vials with a seal diameter of 20mm and an elastomeric stopper. The Vial2Bag Advanced 20mm Admixture Device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV administration set. \n\nThe device does not contain any medicinal substances and there are no additional accessories needed or provided with the Vial2Bag Advanced 20mm Admixture Device for the device to meet its intended purpose.\nComponent: No", "code_info": "Lot Code: Recall Product 1: Product Code 6080030, Lot# K188, UDI (01)10850022888011(17)270430(10)K188\\F(90)36098150\\F(91)6070030\n\nRecall Product 2: Product Code 6080030, Lot# K194, UDI (01)10850022888011(17)270430(10)K194\\F(90)36098150\\F(91)6070030", "firm_fei_number": "3015176617", "recalling_firm": "West Pharmaceutical Services AZ, Inc.", "address_1": "7400 E Tierra Buena Ln Ste 101 7400 E Tierra Buena Ln", "address_2": "Ste 101", "city": "Scottsdale", "state": "AZ", "postal_code": "85260-1795", "additional_info_contact": "Michele Polinsky\n1-610-8503279", "reason_for_recall": "Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.", "root_cause_description": "Environmental control", "action": "On 09/24/2024, the firm emailed an \"URGENT: MEDICAL DEVICE RECALL\" Letter informing customers that due to possible package damage during shipping and transportation, which may result in breach in sterile barrier that compromises the safety and efficacy of the devices.\n\nDistributor are instructed to:\n1. Examine their inventory and quarantine Affected Product subject to this voluntary\nrecall.\n2. If the Affected Product was distributed to additional customers, send them this letter.\n3. Follow up with each account/customer to locate and identify all Affected Product in Appendix 1 and establish the number of units of Affected Product in possession of each\naccount/customer.\n4. Complete the Recall Acknowledgement and Receipt Form below and return (via\nemail) to recall@westpharma.com when complete responses are available (See attached\nform).\n\nCustomers/Users are instructed to:\n1. If they have any Affected Product in their inventory, immediately discontinue use,\nremove it from inventory and quarantine the product to prevent inadvertent use.\n2. Contact Progressive Medical Inc. (PMI), 997 Horan Drive Fenton, Missouri 63026-2401 to schedule return of Affected Products.\nx 1-800-969-6331; 8am to 5pm, Central Time, Monday through Friday\n3. Complete the Recall Acknowledgement and Receipt Form and return to Linda\nBagby by email at cs@progressivemedinc.com within 5 days, even if customers no longer have any Affected Product in their possession (See attached form). This will allow West to document receipt of this letter.\n\nFor questions or assistance - contact West's U.S. distributor Progressive Medical Inc at 1-800-969-6331, 8am to 5pm Central Time Monday thru Friday or as cs@progressivemedinc.com", "product_quantity": "129600", "distribution_pattern": "A U.S. Distributor, Progressive Medical Inc. (PMI) currently supplies the Vial2Bag Advanced 20mm Admixture Device to hospitals in the U.S. (end user). PMI distributed the impacted Vial2Bag Advanced 20mm Admixture Device lots to the end users.\n\nU.S.: Distributor located in MO\nU.S. Customers: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MD, MI, MN, MO, MS, NC, NE, NM, NV, NY, OH, OK, OR, PA,SC, TN, TX, UT, WA, and WI.", "openfda": { "k_number": [ "K860703", "K860610", "K213513", "K923966", "K950305", "K091389", "K172631", "K022523", "K923782", "K250345", "K832347", "K926071", "K203674", "K232055", "K920015", "K092246", "K243404", "K133602", "K140442", "K101309", "K142600", "K200893", "K955896", "K230988", "K904225", "K161800", "K070584", "K994323", "K041564", "K130179", "K202732", "K990711", "K900585", "K240748", "K072511", "K241976", "K852882", "K955622", "K220856", "K921031", "K062482", "K120424", "K133097", "K090917", "K812928", "K080174", "K243486", "K910793", "K024239", "K230464", "K023747", "K051669", "K212530", "K955594", "K013523", "K240940", "K151423", "K192154", "K110023", "K853212", "K121182", "K172884", "K860113", 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"3011802635", "2022435", "3003094851", "3003015552", "1928237", "3003767881", "1217831", "3005042488", "1035907", "3002807038", "3030446844", "3005053560", "2245590", "3004201393", "3030626857", "1000632857", "3002807555", "3014579161", "1019003", "3003807466", "3033527281", "3012410077" ], "device_name": "Set, I.V. Fluid Transfer", "medical_specialty_description": "General Hospital", "regulation_number": "880.5440", "device_class": "2" } } ] }