FDA Device recall Z-2554-2019
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V…
- FDA Device
- Class II
- terminated
- Published 2019-10-02
On 2019-10-02 the FDA classified a Class II recall of Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V… by Smiths Medical Asd, citing customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured prior to November 10, 2017, may experience wireless network connectivity issues on….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2554-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-15 |
| Published | 2019-10-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Smiths Medical Asd |
| Distribution | US |
Product
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.
Reason
Customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured prior to November 10, 2017, may experience wireless network connectivity issues on certain pumps due to a potential Radio Module issue on some Medfusion¿ 4000 pumps.
Identifiers
| code_info | Model Numbers (Serial Numbers): a. 4000-0100-50 (2000245, 2000246, 2000247, 2000248, 2000251, 2000252, 2000254, 20…Model Numbers (Serial Numbers): a. 4000-0100-50 (2000245, 2000246, 2000247, 2000248, 2000251, 2000252, 2000254, 2000255, 2000256, 2000257, 2000258, 2000260, 2000261, 2000264, 2000265, 2000267, 2000268, 2000269, 2000270, 2000272, 2000273, 2000274, 2000276,2000277, 2000278, 2000279, 2000280, 2000281, 2000282, 2000283, 2000284, 2000285, 2000286, 2000287, 2000288, 2000290, 2000291, 2000297, 2000298, 2000299, 2000300, 2000302, 2000304, 2000308, 2000309, 2000310, 2000311, 2000312, 2000313, 2000314, 2000315, 2000317, 2000318, 2000320, 2000321, 2000322, 2000324, 2000325, 2000326, 2000329, 2000331, 2000332, 2000336, 2000338, 2000341, 2000343, 2000345, 2000346, 2000348, 2000349, 2000352, 2000353, 2000355, 2000356, 2000358, 2000359, 2000360, 2000363, 2000364, 2000366, 2000370, 2000371, 2000374, 2000375, 2000376, 2000377, 2000379, 2000380, 2000381, 2000383, 2000385, 2000386, 2000387, 2000388, 2000389, 2000390, 2000392, 2000393, 2000395, 2000396, 2000403, 2000408, 2000409, 2000413, 2000415, 20 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2554-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.