{ "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": "204902", "product_res_number": "Z-0668-2024", "event_date_initiated": "2023-12-06", "event_date_posted": "2024-01-05", "recall_status": "Open, Classified", "res_event_number": "93503", "product_code": "DXZ", "k_numbers": [ "K223052" ], "product_description": "PERI-GUARD SUPPLE, Product Codes: \na)\tSPG1016: 10X16 CM US, TS; \nb)\tSPG0404: 4 X 4 CM US, TS; \nc)\tSPG0608: 6 X 8 CM US, TS; \nd)\tSPG0814: 8 X 14 CM US, TS; \ne)\tPC1016SNBIO: 10X16 CM US; \nf)\tPC0404SNBIO: 4X4 CM US; \ng)\tPC0608SNBIO: 6X8 CM US; \nh)\tPC0814SNBIO: 8X14 CM US", "code_info": "a)\tSPG1016: UDI/DI 85412818429, \nb)\tSPG0404: UDI/DI 85412818672, \nc)\tSPG0608: UDI/DI 85412818313, \nd)\tSPG0814: UDI/DI 85412818375, \ne)\tPC1016SNBIO: UDI/DI 85412530710, \nf)\tPC0404SNBIO: UDI/DI 85412530642, \ng)\tPC0608SNBIO: UDI/DI 85412530673, \nh)\tPC0814SNBIO: UDI/DI 85412530697,\nAll serial numbers", "firm_fei_number": "1417572", "recalling_firm": "Baxter Healthcare Corporation", "address_1": "1 Baxter Pkwy", "city": "Deerfield", "state": "IL", "postal_code": "60015-4625", "additional_info_contact": "Center for One Baxter\n800-422-9837", "reason_for_recall": "Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).", "root_cause_description": "Under Investigation by firm", "action": "Baxter issued an IMPORTANT PRODUCT INFORMATION to its consignees on 12/06/2023 via USPS first class mail. The notice explained the issue, potential hazard involved, and requested the following: \nActions to be Taken by Customers:\n1. Healthcare providers may continue to safely use the products listed above while\nfollowing the associated Instructions for Use.\n2. Cease any further distribution of the Cardiovascular Surgery marketing brochure\nfor the products listed above. All copies of this marketing brochure should be\npromptly discarded. The brochure reference number, US-AS46-220001, can be\nfound at the bottom of the last page of the brochure.\n3. If you received this communication directly from Baxter, please\nacknowledge receipt by responding on our customer portal at\nhttps://BaxterFieldActionCustomerPortal.onprocess.com, even if you do\nnot have any inventory. Log in to the portal using the account number listed on\nthe enclosed reply form instruction sheet. Acknowledging receipt of this\nnotification will prevent you from receiving repeat notices. If you do not complete\nthe acknowledgement, you will receive a phone call from OnProcess Technology\non behalf of Baxter to confirm your receipt of this notification.\n4. If you purchased this product from a distributor, please note that responding on\nthe Baxter customer portal is not applicable. If a response is requested by your\ndistributor or wholesaler, please respond to the supplier according to their\ninstructions.\n5. If you distributed a copy of this brochure to other facilities or departments within\nyour institution, please forward a copy of this communication to them.\n6. If you are a dealer, wholesaler, distributor/reseller, or original equipment\nmanufacturer (OEM) that distributed any copies of the brochure to other facilities,\nplease distribute this notification to customers and check the associated box on\nthe customer portal.\n\nFor general questions, contact Baxter Healthcare Center for Service at 888-229-0001,\nbetwe", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K910464", "K041716", "K111187", "K101866", "K022093", "K833021", "K831516", "K921895", "K003467", "K905496", "K955349", "K992776", "K162506", "K011487", "K943736", "K791792", "K962342", "K091626", "K963368", "K060396", "K770835", "K240775", "K931386", "K982810", "K151865", "K974914", "K811872", "K984526", "K964467", "K812254", "K130872", "K942010", "K031586", "K082139", "K152127", "K881508", "K905073", "K971726", "K993288", "K821532", "K821717", "K140789", "K983602", "K914450", "K020233", "K921659", "K953425", "K003070", "K090637", "K840262", "K200955", "K994032", "K963967", "K823345", "K830806", "K101740", "K081438", "K041736", "K021129", "K052416", "K122306", "K953289", "K001785", "K142461", "K811841", "K930950", "K833763", "K912107", "K842066", "K040415", "K012098", "K031948", "K973178", "K020132", "K051405", "K012248", "K914448", "K801764", "K972201", "K963611", "K001662", "K830863", "K122105", "K063349", "K040162", "K142447", "K760516", "K940906", "K112683", "K162579" ], "registration_number": [ "9612515", "9612501", "2210968", "1060680", "1526611", "1018233", "1055236", "3002719998", "1220948", "3018094310", "3045042524", "1416980", "1614993", "1647149", "1835959", "3045857302", "3005381997", "3009672666", "3041851334", "3010097171", "3031160994", "3007791599", "3004365956", "3017102971", "9680759", "3006082230", "1047843", "1043214", "2183620", "2024024", "2020394", "3010407203", "3004681519", "1018470", "3010041511", "3019716369", "3010162973", "1450662", "3011137372", "1054241", "2320762", "3002924436", "3006017180", "1000393132", "3005636544", "1221601", "1640201", "3003639970", "3007284313", "2015691", "1063481", "3005064037", "3010452421", "3006638824", "2648650" ], "fei_number": [ "3002807041", "3003495548", "2210968", "3005747797", "3002807088", "1526611", "1018233", "1000112877", "3002719998", "1220948", "3018094310", "3045042524", "1416980", "1614993", "3002808437", "1000208624", "3045857302", "3005381997", "3009672666", "3041851334", "3010097171", "3031160994", "3002707083", "3007791599", "3003040625", "3004365956", "3017102971", "3006082230", "1047843", "1043214", "1000112968", "2183620", "1000306139", "2024024", "2020394", "3010407203", "1018470", "3010041511", "3003870583", "3019716369", "1450662", "3002924436", "3006017180", "1000393132", "3002340648", "1221601", "3005636544", "3003639970", "3007284313", "2015691", "3001451326", "3005064037", "3010452421", "3006638824", "2648650" ], "device_name": "Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3470", "device_class": "2" } } ] }