FDA Device recall Z-1767-2017
CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO
- FDA Device
- Class II
- terminated
- Published 2017-04-19
On 2017-04-19 the FDA classified a Class II recall of CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO by Smiths Medical Asd, citing 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 repres….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1767-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-17 |
| Published | 2017-04-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smiths Medical Asd |
| Distribution | 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 |
Product
CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
Reason
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.
Identifiers
| code_info | 46X817, 46X829, 46X899, 46X828, 46X896, 46X990, 46X831, 46X897, 46X1001. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1767-2017%22
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