{ "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": "2026-04-29", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Saint Paul", "state": "MN", "country": "United States", "classification": "Class I", "openfda": {}, "product_type": "Devices", "event_id": "61247", "recalling_firm": "Smiths Medical ASD, Inc.", "address_1": "1265 Grey Fox Rd", "address_2": "N/A", "postal_code": "55112-6929", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Visit", "distribution_pattern": "Worldwide Distribution -- USA, including the state of CA, and country of Canada.", "recall_number": "Z-2107-2012", "product_description": "Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.", "product_quantity": "607 pumps (257 USA, 350 Canada)", "reason_for_recall": "Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe\u001d alarm. When the device exhibits this failure mode, visual and audible alarms will sound and the device ceases operation.", "recall_initiation_date": "20120214", "center_classification_date": "20120801", "termination_date": "20121114", "report_date": "20120808", "code_info": "2000245 2000246 2000247 2000248 2000249 2000250 2000251 2000252 2000253 2000254 2000255 2000256 2000257 2000258 2000259 2000260 2000261 2000262 2000263 2000264 2000265 2000266 2000267 2000268 2000269 2000270 2000271 2000272 2000273 2000274 2000275 2000276 2000277 2000278 2000279 2000280 2000281 2000282 2000283 2000284 2000285 2000286 2000287 2000288 2000289 2000290 2000291 2000292 2000293 2000294 2000295 2000296 2000297 2000298 2000299 2000300 2000301 2000302 2000303 2000304 2000305 2000307 2000308 2000309 2000310 2000311 2000312 2000313 2000314 2000315 2000316 2000317 2000318 2000319 2000320 2000321 2000322 2000323 2000324 2000325 2000326 2000327 2000328 2000329 2000330 2000331 2000332 2000333 2000334 2000336 2000337 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