{ "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": "2026-10-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "213282", "product_res_number": "Z-1662-2025", "event_date_initiated": "2025-04-10", "event_date_posted": "2025-05-07", "recall_status": "Open, Classified", "res_event_number": "96628", "product_code": "MEA", "k_numbers": [ "K170982" ], "product_description": "CADD Solis HSPCA Pump\n\n***Updated 5/27/26***\nScope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope:\n\nPUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA\n21-2111-0403-51\nPUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH, 1/EA\n21-2111-0403-78\nPUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, ENGLISH, 1/EA\n21-2112-0403-51\nPUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, FRENCH, 1/EA\n21-2112-0403-02\nPUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA \n21-2111-0300-01\nPUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA \n21-2111-0300-50\nPUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA \n21-2112-0300-01\nPUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, FRENCH 1/EA \n21-2112-0300-02\nPUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA\n21-2112-0300-50\nPUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA \n21-2101-51\nPUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.1, CE ENGLISH 1/EA\n21-2111-0401-78\nPUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.2, CE ENGLISH 1/EA \n21-2111-0402-78\nPUMP KIT, CADD-SOLIS, MDL 2110, v4.0, ENGLISH 1/EA\n21-2111-0400-51\nPUMP KIT, CADD-SOLIS, MDL 2110, v4.0, YELLOW, ENGLISH 1/EA \n21-2112-0400-51\nPUMP KIT, CADD-SOLIS, MDL 2110, V4.1, CE ENGLISH 1/EA \n21-2111-0401-51\nPUMP KIT, CADD-SOLIS, MDL 2110, V4.1, YELLOW, CE ENGLISH 1/EA \n21-2112-0401-51\nPUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA \n21-2111-0402-51\nPUMP KIT, CADD-SOLIS, MDL 2110, V4.2, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA\n21-2112-0402-78\nPUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA \n21-2112-0402-51\nPUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA \n21-2111-0100-51\nPUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA \n21-2112-0100-51", "code_info": "Affected CADD-Solis Software Versions: 4.0, 4.1, 4.2, 4.2.1, 4.3\n\nUDI-DI:\n\n4546027095675\n4546027095682\n10610586034787\n10610586038778\n10610586038785\n10610586038808\n10610586038822\n10610586039232\n10610586041037\n10610586041051\n15019517099690\n15019517101003\n15019517101010\n15019517101034\n15019517101041\n15019517128697\n15019517135343\n15019517154290\n15019517154887\n15019517154924\n15019517154979\n15019517154986\n15019517154993\n15019517155006\n15019517155013\n15019517155044\n15019517246735\n15019517247008\n15019517247169\n15019517247176\n15019517247183\n15019517247206\n00610586038900\n00610586039310\n04546027095620\n04546027095637\n04546027095644\n04546027095668\n04546027095699\n04546027095705\n04546027095712\n04546027095729\n04546027095736\n04546027095897\n04546027095903\n04546027095910\n04546027422983\n04546027424116\n04546027424130\n04546027424147\n04546027424178\n04546027424185\n04546027424192\n04546027424208\n04546027424598\n05019517154934\n05019517155108\n10610586031854\n10610586032950\n10610586033933\n10610586033940\n10610586035357\n10610586035395\n10610586035401\n10610586035418\n10610586035432\n10610586035456\n10610586035494\n10610586035548\n10610586038792\n10610586038839\n10610586038860\n10610586038891\n10610586038914\n10610586038921\n10610586038938\n10610586038952\n10610586038969\n10610586038983\n10610586038990\n10610586039010\n10610586039041\n10610586039065\n10610586039072\n10610586039089\n10610586039195\n10610586039256\n10610586039270\n10610586039409\n10610586039416\n10610586039430\n10610586039447\n10610586039454\n10610586039461\n10610586039478\n10610586039485\n10610586039492\n10610586041822\n30610586035337\n30610586035344\n30610586035368\n30610586035511\n30610586039205\n30610586039397\n35019517128677\n35019517128684\n35019517128691\n35019517128721\n35019517128738\n35019517128745\n35019517128769\n35019517128783\n35019517128837\n35019517135316\n35019517135323\n35019517135330\n35019517135354\n35019517135361\n35019517154850\n35019517154867\n35019517154874\n35019517154904\n35019517154911\n35019517154942\n35019517154959\n35019517154966\n35019517155055\n35019517155062\n35019517155079\n35019517155086\n35019517155130", "firm_fei_number": "3012307300", "recalling_firm": "Smiths Medical ASD, Inc.", "address_1": "6000 Nathan Ln N", "city": "Minneapolis", "state": "MN", "postal_code": "55442-1690", "additional_info_contact": "Technical Support\n800-241-4002", "reason_for_recall": "Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.", "root_cause_description": "Software design", "action": "Firm began notifying customers on April 10, 2025 via letters titled \"Urgent Medical Device Correction.\"\n\nCustomers were instructed to validate any wireless network changes or updates to hospital network settings with the pump/communication module to ensure compatibility of the wireless connection before deploying network setting changes or updates to the production environment.\n\nIf the alarm recurs or is unable to be cleared by power cycling the pump, the customer should revert to prior compatible network settings or turn off the wireless function of the communication module.\n\nThe firm will also address the issue with a software update. Smiths Medical will contact customers to schedule implementation of the software update once it is available.\n\n***Updated 5/28/2026***\n\nOn 5/27/26, firm revised the scope of the action to apply specifically to CADD customers using the wireless system. All current wireless customers, as well as any customers who upgrade to wireless, will receive the updated CADD firmware connection. All future implementations - both wireless and non-wireless - will include the corrected CADD firmware.", "product_quantity": "US: 83,833 items ; OUS: 71,843 items", "distribution_pattern": "Worldwide - US Nationwide distribution.", "openfda": { "k_number": [ "K092313", "K130394", "K030661", "K914502", "K920637", "K020418", "K915270", "K943310", "K051253", "K013822", "K032233", "K910257", "K915063", "K043299", "K022203", "K990312", "K911791", "K042800", "K002739", "K031566", "K043256", "K934551", "K020421", "K982839", "K162165", "K921994", "K143612", "K002434", "K033054", "K072144", "K170982" ], "registration_number": [ "3010082909", "3009746061", "3013764800", "9680425", "1055236", "1054241", "1043214", "3013652261", "3010381606", "3009456923", "2029275", "3008717264", "3012337868", "9617604", "2032112", "9615050", "3003879246", "3024706751", "3012302888", "3013319212", "3007738736", "1047843", "3004906872", "2024064", "2025695", "2016493", "3011270181", "1319660", "3002879653", "3018071447", "9610825" ], "fei_number": [ "3002806469", "3010082909", "1000112968", "3009746061", "3013764800", "1000112877", "3002558692", "1043214", "3013652261", "3010381606", "3009456923", "3008717264", "3012337868", "3003879246", "1000306431", "3024706751", "3012302888", "3013319212", "3007738736", "1047843", "3004906872", "2024064", "3007596547", "2025695", "2016493", "3011270181", "1000136478", "3002879653", "3018071447", "3003076831", "3002999813" ], "device_name": "Pump, Infusion, Pca", "medical_specialty_description": "General Hospital", "regulation_number": "880.5725", "device_class": "2" } } ] }