{ "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": "178020", "product_res_number": "Z-0593-2020", "event_date_initiated": "2019-11-06", "event_date_created": "2019-12-02", "recall_status": "Terminated", "event_date_terminated": "2021-11-19", "res_event_number": "84316", "product_code": "KCY", "product_description": "Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.", "code_info": "GTIN: 37613154599296, Lot Numbers 60180374, 60181194", "firm_fei_number": "1811755", "recalling_firm": "Stryker Instruments Div. of Stryker Corporation", "address_1": "4100 E Milham Ave", "city": "Portage", "state": "MI", "postal_code": "49002-9704", "reason_for_recall": "There is a potential for the cuff to leak air leading to a loss of vascular occlusion.", "root_cause_description": "Under Investigation by firm", "action": "Urgent Medical Device Recall Notification letters dated 11/6/19 were sent to customers. \n\nActions to be taken:\n1. Immediately review this Recall Notification and the Business Reply Form.\n2. Immediately check all stock areas and/or operating room storage for affected products. Quarantine and\ndiscontinue use of any Color Cuff Disposable Tourniquet Cuffs identified in this Notification.\n3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this Notification and identify how\nmany affected items are currently in your inventory. Please complete and return the BRF even if you dont\nhave any affected product on hand. Return the completed BRF via fax (8665212762) or email to\nkara.spath@stryker.com.\nNote: Your signature on the BRF indicates that you received and understand this Notification and have\nfollowed the instructions in the Notification.\n4. If you have further distributed this product, please forward copies of this Notification and the BRF to all\naffected locations, for each location to complete and return. Even if you have distributed all product to\nanother location, please complete a BRF and indicate each location that received product.\n5. If the BRF for your facility indicates that recalled product is currently on hand, a shipping label will be\nprovided which should be used to return recalled product. Upon receipt of the recalled product, a credit\nwill be applied to your account.", "product_quantity": "16,380 total", "distribution_pattern": "Worldwide distributions - US Nationwide distributions in the states of AL, CD, HI, IA, ID, IN, KS, KY, MA, ME, MI, MN, MT, NC, NE, NH, NJ, NV, NY, OK, OR, PA, SC, SD, TN, VA, WI, WV, and WY. Countries of Argentina, Australia, Canada, and Netherlands.", "openfda": { "k_number": [ "K954201", "K840206", "K910512", "K870784", "K924273", "K925033", "K953953", "K955552", "K112874", "K780988", "K050411", "K954103", "K071140", "K880020", "K841558", "K942303", "K900104", "K162365", "K952038", "K123553", "K202919", "K945167", "K933994", "K791759", "K890014", "K813231", "K871982", "K940615", "K012632", "K842963", "K860095", "K910449", "K853802", "K860463" ], "registration_number": [ "3014830562", "3010595915", "3008264111", "3005173255", "3031700059", "3006128321", "1058584", "2029275", "1822565", "3013783488", "3009750712", "3008381116", "9680215", "9681444", "3033511104", "3014313732", "3015495690", "3015542154", "3006950086", "3016445580", "1421307", "3016678045", "3031887985", "2650143", "1528668", "3006703573", "3007478714", "3004116008", "3023228837", "2011171", "3006975482", "3011277660", "3006535925", "3013846070", "1720929", "3030516433", "9611559", "9680579", "3011642792", "1048735", "3015309643", "3034520", "3005621729", "3010190204", "2184171", "3009350690", "3003244954", "1649518", "1018470", "3010291427", "3014023545", "3009605245", "1220351", "1921846", "3030733800", "3012494290", "3025434447", "3012421607", "3004905643", "3010883047", "1422634", "3004824601", "3007997036", "3002907620", "3014739961", "3032391", "3013730933", "3045058049", "3011683674", "3020163307", "1423537", "1721504", "1043214", "3004727093", "3015280549", "3010410654", "3011185837", "1650907", "3016950436", "3009039068", "1818910", "3030153385", "8010482", "1722028", "3009056984", "9613910", "3016965559", "3016764932", "2032098", "3033589330", "1526350", "3012536737", "8040278", "9611283", "3010759902", "2648666", "3033773618", "3038700849", "3015225571", "3014126909", "8010939", "3005698350", "3010273872", "3015967359", "2320762", "3010123014", "2528981", "3015207155", "3012276218" ], "fei_number": [ "3014830562", "3010595915", "3008264111", "3005173255", "1000219637", "3031700059", "3006128321", "3001236905", "1000117351", "3013783488", "1000203464", "3003350313", "3009750712", "3008381116", "3003040625", "2648209", "3033511104", "3014313732", "1000514656", "3012599796", "3015495690", "3015542154", "3006950086", "3016445580", "1421307", "3016678045", "3031887985", "3006703573", "3007478714", "3004216008", "3004116008", "3023228837", "3003748933", "2011171", "3006975482", "3011277660", "3001236277", "3006535925", "3013846070", "1720929", "3030516433", "1000220733", "1000306431", "3011642792", "1048735", "3015309643", "3005621729", "3010190204", "3009350690", "3003244954", "1018470", "3003058448", "3003255513", "3010291427", "3002681132", "3014023545", "3009605245", "3002808440", "1220351", "1921846", "3030733800", "3012494290", "3025434447", "3012421607", "3004905643", "3004824601", "3001084824", "3007997036", "3002907620", "3014739961", "3013730933", "3045058049", "3011683674", "3020163307", "1721504", "1043214", "3004727093", "3015280549", "3010410654", "1000136409", "3011185837", "3016950436", "3009039068", "1000139815", "1818910", "3004574120", "3030153385", "3009056984", "1000292048", "3016965559", "1526350", "3016764932", "3033589330", "3012536737", "3010759902", "2648666", "3033773618", "3002299608", "3038700849", "3015225571", "3002806816", "3014126909", "3005698350", "3010273872", "3015967359", "3010123014", "2528981", "3015207155", "3012276218" ], "device_name": "Tourniquet, Pneumatic", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.5910", "device_class": "1" } } ] }