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U.S. Department of Health and Human Services

Medical Devices

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Baxter Intravenous Filter Sets

Class I Recall
Date Recall
October 17, 2002
Baxter Intravenous Filter Sets containing 0.22 micron filters
Catalog numbers: 2N3332, 2N3333, 2N3342, 2N3347, 2N3350, 2C5683, 2C5693, 1C8384, 1C8412, 1C8483, 1C8499, 1C8546, 1C8560, 1C8577, 1C8600, 1C8633, 1M8516, 1M8516Y, 1M8522, 1M8522Y, 1M8527, 1M8527Y, 1M8529.
These IV sets are intended to be a sterile pathway for the administration of a variety of intravenous fluids. They are used on newborns and on adult and pediatric patients whose immune system is compromised.
Recalling Firm:
Baxter Healthcare Corporation
Rt. 120 and Wilson
Round Lake, IL 60073
Reason for Recall:
The filters in the IV sets may contain a 1.2 micron filter instead of a 0.22 micron filter. If a 1.2 micron filter is used as a 0.22 micron, the filter will fail to function as intended and could result in the infusion of particles leading to a blockage of small vessels and/or infusion of bacteria creating a potential for infection.
Public Contact:
Christine Brown Strysik
Manager, Product Surveillance
Medication Delivery
FDA District:
Chicago, Illinois
FDA Comment:
FDA considers that the probability of life threatening consequences is likely to occur by use of these devices until the correction is made.