medical MODERATE Updated 2017-04-19

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

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Recalled Product

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

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Hazard / Issue

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.

Issued by

FDA

Affected States: 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

Lot/Code Info: 46X817, 46X829, 46X899, 46X828, 46X896, 46X990, 46X831, 46X897, 46X1001.

✅ What Should You Do?

1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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View official government recall

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

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