Company: Smiths Medical ASD Inc.
Date of Enforcement Report: 10/2/2019
Class II

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.

• Recall Number: Z-2554-2019

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.

RECALLING FIRM/MANUFACTURER

Smiths Medical ASD Inc. on 10/2/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

20,884 devices

DISTRIBUTION

US Nationwide and International