FDA-Device2017-04-19Class II
CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
Smiths Medical ASD Inc.
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?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief