FDA-Device2017-04-19Class II
CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
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.
Sold states
US:AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WV, WY. OUS: Canada
Affected count
38,415 (38145 US; 2268 OUS)
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1767-2017Don't want to check this manually?
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