Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
Check against the official notice below — it lists the full affected range.
Smiths Medical ASD Inc. is recalling approximately 58,671 units of Medfusion Syringe Pump models 4000-0100-50, 4000-0101-249, 4000-0101-50, 4000-0101-51, 4000-0101-78, 4000-0105-249, and 4000-0105-51 worldwide, including throughout the United States and the U.S. Virgin Islands. The pumps have multiple software and hardware issues that could interrupt medication therapy or cause over-infusion of medication, including problems with audible alarms, battery alarms, infusions continuing after system failures, incorrect dose displays, and false alarms.
The affected pumps have been distributed across numerous countries and many specific serial numbers have been identified. The recall notice does not specify what consumers or healthcare facilities should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001
Reason for recall: Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001 Distribution: Worldwide distribution. US nationwide including US Virgin Islands, Countries of: AE, AL, AT, AU, BE, BM, BN, BS, CA, CH, CL, CY, CZ, DE, DK, DO, ES, FI, FR, GB, HK, HU, ID, IE, IL, IN, IR, IT, KR, KW, LB, LK, MU, MX, MY, NL, NZ, OM, PA, PH, PK, PL, PT, QA, SA, SE, SG, TR, TT, VI, and VN. Quantity: 58671 units Lot/code info: Model 4000-0100-50: UDI 061058603532, Serial Numbers: 2000380, 2000342, 2000351, 2000485, 2002080, 2000501, 2000275, 2002089, 2000528, 2000386, 2002086, 2000555, 2002083, 2000530, 2000495, 2002084, 2002087, 2000452, 2002092, 2000489, 2000283, 2002098, 2000309, 2000315, 2000434, 2002094, 2000442, 2000427, 2000334, 2000388, 2000415, 2000270, 2000364, 2000401, 2002103, 2000377, 2000579, 2002101, 2000352, 2002090, 2000474, 2000456, 2002102, 2000307, 2000323, 2000368, 2000337, 2000429, 2000466, 2000296, 2000294, 2000340, 2000457, 2000412, 2000339, 2000543, 2000470, 2000319, 2000399, 2000539, 2002095, 2000404, 2000384, 2000250, 2000328, 2002097, 2000564, 2000266, 2000350, 2000446, 2000372, 2000569, 2000289, 2000344, 2000253, 2000416, 2000259, 2000367, 2000293, 2000418, 2000422, 2000459, 2000463, 2000435, 2000335, 2000295, 2000562, 2000394, 2000407, 2000510, 2000373, 2000249, 2000292, 2000301, 2000557, 2000303, 2000378, 2000327, 2000538, 2000263, 2000410, 2000420, 2000424, 2000514, 2000536, 2000488, 2000448, 2000262, 2000354, 2000271, 2002091, 2002093, 2002096, 2002099, 2002100, 2002085, 2002081, 2002082, 2000534, 2000535, 2000580, 2000581, 2000582, 2000583, 2000584, 2000567, 2000568, 2000570, 2000571, 2000572, 2000573, 2000574, 2000575, 2000576, 2000577, 2000578, 2000505, 2000506, 2000507, 2000508, 2000509, 2000511, 2000512, 2000513, 2000515, 2000516, 2000517, 2000518, 2000519, 2000520, 2000521, 2000522, 2000523, 2000524, 2000525, 2000526, 2000527, 2000529, 2000531, 2000532, 200053
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.