| Date Recall Initiated: |
October 17, 2002 |
|---|---|
| Product: |
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. |
| Use: |
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 1-888-229-0001 |
| 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. |
| For additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2003/ENF00783.html. Scroll down to “Recalls and Field Corrections: Devices – Class I”. |
Updated April 24, 2003
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