{ "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": 2 } }, "results": [ { "cfres_id": "213267", "product_res_number": "Z-1667-2025", "event_date_initiated": "2025-04-10", "event_date_posted": "2025-05-07", "recall_status": "Open, Classified", "res_event_number": "96620", "product_code": "MEA", "k_numbers": [ "K072144", "K130394", "K170982" ], "product_description": "CADD-Solis HPCA Ambulatory Infusion Pump; \nModel/Number:\n\n21-2111-0402-09-KYO\n21-2111-0402-09-KYO\nCADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP\n21-2111-0300-09_LOAN\nCADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA\n21-2111-0300-09_CMSA\nCADD Solis PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR FUKUOKA\n21-2111-0300-09_FUK\nCADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR KYOTO\n21-2111-0300-09_KYO\nCADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OKAYAMA\n21-2111-0300-09_OKA\nCADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OOMIYA\n21-2111-0300-09_OMI\nCADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OSAKA\n21-2111-0300-09_OSA\nCADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR SAPPORO\n21-2111-0300-09_SAP\nCADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR TOKYO\n21-2111-0300-09_TOK\nCADD_SOLIS_MODEL 2110_ENGLISH_1/EA\n21-2111-0200-50JP\nCADD-Solis VIP\nCADD-SOLIS V4.2 LOAN FUK\n21-2111-0402-09-FUK\nCADD-SOLIS V4.2 LOAN NAG\n21-2111-0402-09-NAG\nCADD-SOLIS V4.2 LOAN OKA\n21-2111-0402-09-OKA\nCADD-SOLIS V4.2 LOAN OSA\n21-2111-0402-09-OSA\nCADD-SOLIS V4.2 LOAN SAI\n21-2111-0402-09-SAI\nCADD-SOLIS V4.2 LOAN SAP\n21-2111-0402-09-SAP\nCADD-SOLIS V4.2 LOAN TOKE\n21-2111-0402-09-TOKE\nCADD-SOLIS V4.2 LOAN TOKW\n21-2111-0402-09-TOKW\nCADD-SOLIS V4.2 LOAN YELLOW KYO\n21-2112-0402-09-KYO\nCADD-SOLIS V4.2 LOAN YELLOW NAG\n21-2112-0402-09-NAG\nCADD-SOLIS V4.2 LOAN YELLOW YOK \n21-2112-0402-09-YOK\nCADD-SOLIS V4.2 LOAN YOK\n21-2111-0402-09-YOK\nNumber:21-2111-0403-02Part Type:List Number/Finished GoodLifecycle Phase:03-ReleasedDescription:PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, FRENCH, 1/EA\n21-2111-0403-02\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, TRIAL, LOANER, YELLOW, ENGLISH, 1/EA\n21-2112-0403-78\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 TRIAL/LOANER, NA ENGLISH 1/EA\n21-2111-0300-00\nPUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, DANISH 1/EA \n21-2111-0300-12\nPUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, DUTCH 1/EA \n21-2111-0300-06\nPUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, FRENCH 1/EA \n21-2111-0300-02\nPUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, GERMAN 1/EA \n21-2111-0300-03\nPUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, ITALIAN 1/EA \n21-2111-0300-07\nPUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, JAPANESE\n21-2111-0300-09JP\nPUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA \n21-2111-0300-01\nPUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, FRENCH 1/EA \n21-2111-0300-232\nPUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, NA ENGLISH 1/EA \n21-2111-0300-231\nPUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, SWEDISH 1/EA\n21-2111-0300-244\nPUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA \n21-2111-0300-50\nNot\nPUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, PORTUGUESE 1/EA \n21-2111-0300-17\nPUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, SPANISH 1/EA \n21-2111-0300-08\nPUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, SWEDISH 1/EA \n21-2111-0300-14\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, DUTCH 1/EA\n21-2112-0300-06\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, GERMAN 1/EA\n21-2112-0300-03\nPUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA\n21-2112-0300-50\nPUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110,TRIAL/LOANER, NA ENGLISH 1/EA\n21-2112-0300-00\nPUMP KIT, CADD-SOLIS HPCA, MDL 2100, DANISH 1/EA \n21-2101-0200-12\nPUMP KIT, CADD-SOLIS HPCA, MDL 2100, FRENCH 1/EA \n21-2101-0200-02\nPUMP KIT, CADD-SOLIS HPCA, MDL 2100, GERMAN 1/EA \n21-2101-0200-03\nPUMP KIT, CADD-SOLIS HPCA, MDL 2100, ITALIAN 1/EA \n21-2101-02", "code_info": "All CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps\n\nUDI-DI:\n\n10610586034787\n10610586038778\n10610586038785\n10610586038808\n10610586038822\n10610586039232\n10610586041037\n10610586041051\n10610586042591\n10610586042669\n10610586042829\n10610586042836\n15019517084368\n15019517096378\n15019517096385\n15019517096392\n15019517099690\n15019517101003\n15019517101010\n15019517101034\n15019517101041\n15019517126587\n15019517126594\n15019517126600\n15019517126617\n15019517128697\n15019517135343\n15019517149999\n15019517150001\n15019517150292\n15019517154290\n15019517154887\n15019517154924\n15019517154979\n15019517154986\n15019517154993\n15019517155006\n15019517155013\n15019517155044\n15019517246735\n15019517247008\n15019517247169\n15019517247176\n15019517247183\n15019517247206\n00610586038900\n00610586039310\n04546027095620\n04546027095637\n04546027095644\n04546027095668\n04546027095675\n04546027095682\n04546027095699\n04546027095705\n04546027095712\n04546027095729\n04546027095736\n04546027095743\n04546027095897\n04546027095903\n04546027095910\n04546027422983\n04546027424116\n04546027424130\n04546027424147\n04546027424178\n04546027424185\n04546027424192\n04546027424208\n04546027424598\n05019517154934\n05019517155108\n10610586031854\n10610586033933\n10610586033940\n10610586035067\n10610586035357\n10610586035395\n10610586035401\n10610586035418\n10610586035432\n10610586035456\n10610586035494\n10610586038501\n10610586038518\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\n10610586040429\n10610586040443\n10610586040528\n10610586041822\n10610586042607\n10610586042614\n10610586042843\n15019517084382\n15019517084399\n15019517084405\n15019517084412\n15019517084429\n15019517084443\n15019517084450\n15019517084467\n15019517086720\n15019517149517\n15019517149975\n15019517150025\n15019517150032\n15019517150049\n15019517150056\n15019517150063\n15019517150070\n15019517150087\n15019517150094\n15019517150100\n15019517150117\n15019517150124¿\n15019517150131\n15019517150179\n15019517150193\n15019517150216\n15019517150278\n15019517150308\n15019517150315\n15019517150322\n15019517150391\n30610586035344\n30610586035368\n30610586035511\n30610586039205\n30610586039397\n30610586040430\n30610586040539\n35019517128677\n35019517128684\n35019517128691\n35019517128721\n35019517128738\n35019517128745\n35019517128769\n35019517128783\n35019517128837\n35019517135316\n35019517135323\n35019517135330\n35019517135354\n35019517135361\n35019517154850\n35019517154867\n35019517154874\n35019517154904\n35019517154911\n35019517154942\n35019517154959\n35019517154966\n35019517155031\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": "Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.", "root_cause_description": "Labeling design", "action": "On April 10, 2025, the firm notified affected consignees via letters titled \"Urgent Medical Device Correction.\"\n\nCustomers were informed of conditions under which the false Upstream Occlusion Alarm may occur. The USO alarm can be cleared during these conditions by removing the administration from the pump, re-attaching the administration set, and restarting delivery. Customers should verify there is no upstream occlusion present.\n\nThe firm will be making an update to the Infusion Pump Operator's Manual to include these conditions.", "product_quantity": "185,975 US; 127,701 OUS Total", "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" } } ] }