{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196420", "product_res_number": "Z-0264-2023", "event_date_initiated": "2022-10-06", "event_date_posted": "2022-11-18", "recall_status": "Open, Classified", "res_event_number": "90989", "product_code": "PUI", "product_description": "3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape", "code_info": "UDI/DI (01)30707387018741, Lot numbers: 33HJ3C, 33HTFH, 33J9CT, 33JED6, 33JJHN, 33K968, 33KTRH", "firm_fei_number": "2126770", "recalling_firm": "3M Healthcare Business", "address_1": "2510 Conway Ave E", "city": "Saint Paul", "state": "MN", "postal_code": "55144-4147", "additional_info_contact": "3M Health Care Helpline\n800-228-3957 Ext. 7", "reason_for_recall": "During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.", "root_cause_description": "Component change control", "action": "The firm began disseminating an URGENT Product Recall notice their consignees by email or letter beginning 10/06/2022. The notice explained the issue and requested the following:\nDistributors: \n\"Actions Requested:\n1. Immediately discontinue distribution of affected models and lots of 3M\" Steri-Drape\" Surgical Drapes. Reference Attachment 1 for list of models and lots.\n2. Determine if any stock of the affected models and lots remain in inventory.\n3. Complete the Distributor Acknowledgement Form with the following:\n\" Acknowledge that you have read and understood this letter whether or not you have any 3M\" Steri-Drape\" Surgical Drapes in stock at your facility; and\n\" Indicate if you have any product in stock and dispose of this material per facility policy.\n\" Email the completed form to 3MFieldSafetyAction@montage72.com.\n4. Notify any of your customers who have purchased this product using the Customer Letter and Customer Acknowledgement Form provided.\n5. To request credit, contact 3M Health Care Customer Helpline at 1-800-228-3957, option 7 or by email to 3MFieldSafetyAction@montage72.com.\" \n\nDirect accounts:\n\"Actions Requested:\n1. Immediately cease use of affected models and lots of 3M\" Steri-Drape\" Surgical Drapes. Reference Attachment 1 for list of models and lots.\n2. Determine if any stock of the affected models and lots remain in inventory.\nNOTE: if you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them.\n3. Complete the Customer Acknowledgement Form with the following:\n\" Acknowledge that you have read and understood this letter whether or not you have any 3M\" Steri-Drape\" Surgical Drapes in stock at your facility; and\n\" Indicate if you have any product in stock and dispose of this material per facility policy.\n\" Email the completed form to 3MFieldSafetyAction@montage72.com.\n4. To request credit, contact 3M Health Care Customer Helpline at 1-800-228-3957, option 7 or by email t", "product_quantity": "17,200 units", "distribution_pattern": "Worldwide distribution.", "openfda": { "registration_number": [ "3020983323", "3009544661", "3012494290", "3011396687", "3013595964", "1063300", "3014146451", "3015527848", "3005997949", "3027588012", "3007050292", "3010684280", "3011063460", "3012345110", "3014151865", "3029995180", "3007378235", "3034204758", "3003965134", "3013557562", "3012627460", "3017887108", "3009443860", "3004950768", "3002807090", "3009719225", "1928237", "3008352384", "3014635169", "3005728058", "3010208880", "3034604687", "3007029063", "3015499242", "1121091", "8043484", "3009114792", "1721676", "3011767135", "9680455", "3015173212", "3012595397", "8010690", "1721686", "3031180770", "3044563550", "3010155681", "3038718579", "3007139365", "3034629649", "3030626857", "1417592", "3013575574", "3011390076", "9616088", "3015042209", "3043535425", 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"3010155661", "3016761372", "3003807323", "3016096100", "2433012", "3010493171", "3014409525", "3014666579", "3010375076", "3013665681", "3031238659", "3009185973", "3018167761", "3009771004", "1043644", "3033011342", "3031582434" ], "device_name": "Drape, Surgical, Exempt", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4370", "device_class": "2" } } ] }