{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "195430", "product_res_number": "Z-1683-2022", "event_date_initiated": "2022-07-21", "event_date_created": "2022-09-07", "recall_status": "Open, Classified", "res_event_number": "90689", "product_code": "LRP", "product_description": "Medline CHEST TUBE REORDER NO: DYNJ36762A", "code_info": "Model Number: DYNJ36762A\nUDI-DI Code (GTIN Insert/GTIN Case / Lot Number:\n(01)1019348989440/(01)40193489894401 / 21ILA164\n(01)1019348989440/(01)40193489894401 / 21ILA986\n(01)1019348989440/(01)40193489894401 / 21JLA315\n(01)1019348989440/(01)40193489894401 / 21KLA005\n(01)1019348989440/(01)40193489894401 / 21KLA162\n(01)1019348989440/(01)40193489894401 / 21KLA629", "firm_fei_number": "3005595283", "recalling_firm": "Medline Industries Inc.", "address_1": "12001 General Milton", "city": "Laredo", "state": "TX", "postal_code": "78045", "additional_info_contact": "Karin Johnson\n866-359-1704", "reason_for_recall": "Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit", "root_cause_description": "Process control", "action": "On 07/21/2022, Medline Industries, LP send an \"IMMEDIATE ACTION REQUIRED MEDICAL DEVICE RECALL\" Letter via first class mail and email to customers informing them that due to the non-sterile Elastic Adhesive Tape component being placed into the sterile portion of the kit. Placement of this component results in the loss of sterility.\n\nRequired Action:\n1.Immediately check their stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product.\n2.Please use the link and the information below to complete the response form. Please list the quantity of affected product in their inventory on the form. Even if customers do not have any affected product in inventory, please complete and submit the form.\nThe login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-22-094-FG Recall Code: RXXXXXXX\n3.Upon completion of the form, please destroy affected product. Customer's account will receive credit once the response form is submitted.\n4.If customer is a distributor, or has resold or transferred this product to another company or individual, customer is required by FDA regulations to notify them of this recall communication. Have the customers document and destroy any affected product. You should include your customers quantities on your response form.\n\nIf you have any questions, please contact the Recall Department at 866-359-1704.", "product_quantity": "300 kits", "distribution_pattern": "U.S. Nationwide distribution in the state of AL.", "openfda": { "k_number": [ "K940239", "K940444", "K861142", "K935621", "K873290", "K903962", "K922126", "K903544", "K881095", "K873469", "K951811", "K760497", "K905462", "K873439", "K890071", "K874665", "K903963", "K912105", "K963723", "K882275", "K883098", "K940646" ], "registration_number": [ "3007420745", "1030451", "3044150131", "3025663209", "3008559312", "3009158523", "3043164947", "3010583458", "3009340886", "9611579", "3010452421", "3024988980", "8010890", "3006272282", "1820334", "3000199132", "1225691", "8040278", "1066741", "3004122598", "1223662", "2433012", "3042989733", "3007329020", "3009584307", "3008392711", "3010453282", "3005071827", "3016050940", "3009110133", "1045834", "9680411", "9616088", "3003120897", 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