FDAMarch 17, 2017device
CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yellow striped CADD¿ Administration Sets (part number 21-7339-24), incorrectly represent the actual filter size of the product. Although the text description on the IFU correctly identifies the product to include a 0.2 micron filter, the illustration on the IFU identifies the filter size as 2.0 microns.
What to do
FDA enforcement status: Terminated
Brands named
smiths medical asdsmithssmiths medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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