{"recall":{"id":"fda-device-99628","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Medical Action Industries, Inc. 306 recalls Blood Culture Collection Venipuncture Kit 20/Cs","firm":"Medical Action Industries, Inc. 306","date":"2026-07-23","reported":"2026-09-23","status":"Ongoing","classification":"Class II","products":[{"name":"Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood Culture Collection Kit, REF: 81834C. All containing BD ChloraPrep Clear - 1 mL Applicators","code":"77451/20809160195069/343602(5/31/2027), 349005(10/31/2027), 374030(11/30/2027), 375434(12/31/2027), 377632(4/2/2028), 327194(8/31/2026), 375105(3/31/2028), 336074(3/21/2027); 81834B/20809160403324/326214(7/31/2027); 81834C/20809160466602/347551(8/12/2026), 372502(8/10/2026), 374615(10/21/2026), 376461(10/23/2026), 377088(11/6/2026), 373129(9/3/2026), 374033(9/3/2026)","quantity":"6,420","number":"Z-3181-2026","classification":"Class II"}],"reason":"Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may compromise the component's sterile barrier and if used may lead to localized skin or soft tissue infection.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of OH, IN, NC.","nationwide":true,"states":[],"units":"6,420","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99628","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"17e399c8fa4ad051","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99628","record":[{"status":"Ongoing","city":"Arden","state":"NC","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99628","recalling_firm":"Medical Action Industries, Inc. 306","address_1":"25 Heywood Rd","address_2":"N/A","postal_code":"28704-9302","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of OH, IN, NC.","recall_number":"Z-3181-2026","product_description":"Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451;  Blood Culture Kit 20/Cs, REF: 81834B;  Blood Culture Collection Kit, REF: 81834C.    All containing BD ChloraPrep Clear - 1 mL Applicators","product_quantity":"6,420","reason_for_recall":"Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may compromise the component's sterile barrier and if used may lead to localized skin or soft tissue infection.","recall_initiation_date":"20260723","center_classification_date":"20260916","report_date":"20260923","code_info":"77451/20809160195069/343602(5/31/2027), 349005(10/31/2027), 374030(11/30/2027), 375434(12/31/2027), 377632(4/2/2028), 327194(8/31/2026), 375105(3/31/2028), 336074(3/21/2027);  81834B/20809160403324/326214(7/31/2027);  81834C/20809160466602/347551(8/12/2026), 372502(8/10/2026), 374615(10/21/2026), 376461(10/23/2026), 377088(11/6/2026), 373129(9/3/2026), 374033(9/3/2026)","more_code_info":""}]}}