CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
Reported: April 19, 2017 Initiated: March 17, 2017 #Z-1767-2017
Product Description
CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
Reason for Recall
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.
Details
- Recalling Firm
- Smiths Medical ASD Inc.
- Units Affected
- 38,415 (38145 US; 2268 OUS)
- Distribution
- 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
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.. Recalled by Smiths Medical ASD Inc.. Units affected: 38,415 (38145 US; 2268 OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 19, 2017. Severity: Moderate. Recall number: Z-1767-2017.
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