CADD¿ Administration Set — Class II medical device recall Z-1767-2017
Terminated recall by Smiths Medical ASD Inc., reported 2017-04-19, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yellow striped C
| Recall number | Z-1767-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2017-03-17 |
| Classified | 2017-04-10 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2019-07-03 |
| Distributed | 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 |
| Countries outside the US | CA |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1767-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.