FDAFDA · Food and drugs·Recall number Z-1767-2017
CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
Published April 19, 2017 · Recall initiated: March 17, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD Inc.
- Distributor
- 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
- Lot
- 46X817, 46X829, 46X899, 46X828, 46X896, 46X990, 46X831, 46X897, 46X1001.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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