Smiths Medical ASD Inc. recalls CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.

Recall date

March 17, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1767-2017

FDA classification

Class II

Brand / firm

Smiths Medical ASD Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.