Reported Oct 2, 2019 · Terminated
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names:…
Smiths Medical ASD Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 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. |
- Lot codes and dates
- Model Numbers (Serial Numbers)
3,613 of 3,613 codes
a. 4000-0100-50 (200024520002462000247200024820002512000252200025420002552000256200025720002582000260200026120002642000265200026720002682000269200027020002722000273200027420002762000277200027820002792000280200028120002822000283200028420002852000286200028720002882000290200029120002972000298200029920003002000302200030420003082000309200031020003112000312200031320003142000315200031720003182000320200032120003222000324200032520003262000329
- Model Numbers (Serial Numbers)
- Amount recalled
- 20,884 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Smiths Medical ASD Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.