Reported Mar 28, 2018 · Terminated
Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses
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?
Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses
4 of 4 products
| # | Product as published |
|---|---|
| 1 | 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 |
| 3 | In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician |
| 4 | Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla. |
- Lot codes and dates
Product Codes 3500G3500VX3500-4143500-4023500-0600-2493500-0600-003500-0600-013500-0600-503500-0600-513500-0600-823500-3063500-4153500-500
- Amount recalled
- 16,600 pumps total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump) results in an inability to complete pump programming. Misidentification of a syringe is where the pump misinterprets the syringe size.
This product could cause temporary or reversible health problems — stop using it.
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