Medfusion¿ Model 4000 Syringe Infusion Pump — Class II medical device recall Z-2554-2019
Terminated recall by Smiths Medical ASD Inc., reported 2019-10-02, distributed nationwide. Customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured prior to Novem
| Recall number | Z-2554-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2018-10-15 |
| Classified | 2019-09-23 |
| Reported by FDA | 2019-10-02 |
| Terminated | 2022-10-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 20,884 devices |
| Reason classes | software |
| NDC | 04000-0100-50, 04000-0101-51, 04000-0101-78, 04000-0105-51, 04000-0105-78, 04000-0106-01 |
| Serial numbers | 1030011, 2000246, 2000247, 2000248, 2000249, 2000250, 2000251, 2000252, 2000253, 2000254, 2000255, 2000256, 2000257, 2000258, 2000259, 2000260, 2000261, 2000262, 2000263, 2000264, 2000265, 2000266, 2000267, 2000268, 2000269 and 475 more |
| Model numbers | 1030011, 2000246, 2000247, 2000248, 2000249, 2000250, 2000251, 2000252, 2000253, 2000254, 2000255, 2000256, 2000257, 2000258, 2000259, 2000260, 2000261, 2000262, 2000263, 2000264, 2000265, 2000266, 2000267, 2000268, 2000269 and 475 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2554-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.