CADD Administration Set, 21-7339-24, Rx Only, Sterile EO recallZ-1767-2017 · Smiths Medical ASD Inc. · initiated Mar 17, 2017
Class II Terminated All recalls posted in March 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Packaging process control
What the company is doing
Smiths Medical sent an "Urgent Medical Device Field Safety Notice" dated March 13, 2017. The letter was addressed to "Risk Manager". It provided a list of the Affected devices, Risk to Health, Instructions to Distributors & Customers. Advised consignees to notify their customers. There is no need to return the devices to Smiths Medical. Requested consignees to complete the Urgent Medical Device Field Safety Notice (FSN) Response Form and return to [email protected]. For questions contact Stericycle at 844-265-7407. For further questions regarding this recall , please call (844) 265-7407.
Recall details
- Recall number
- Z-1767-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 17, 2017
- Posted by the FDA
- Mar 30, 2017
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 38,415 (38145 US; 2268 OUS)
- Product code
- FPA
- FDA submissions
- K040636
- 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
Product description
CADD Administration Set, 21-7339-24, Rx Only, Sterile EO.
Code information (models, lots, serial numbers)
46X817, 46X829, 46X899, 46X828, 46X896, 46X990, 46X831, 46X897, 46X1001.
Other devices under the same FDA submission
18 devices cleared under K040636 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- CADD 21-7394-24Icu Medical, Inc. · Set, administration, intravascular2 recalls2 deaths586 reports
- CADD 21-7301-24Icu Medical, Inc. · Set, administration, intravascular4 recalls467 reports
- CADD 21-7322-24Icu Medical, Inc. · Set, administration, intravascular2 recalls391 reports
- CADD 21-7300-24Icu Medical, Inc. · Set, administration, intravascular4 recalls121 reports
- CADD 21-7324-24Icu Medical, Inc. · Set, administration, intravascular2 recalls155 reports
- CADD 21-7349-24Icu Medical, Inc. · Set, administration, intravascular2 recalls135 reports
- CADD 21-7359-24Icu Medical, Inc. · Set, administration, intravascular2 recalls110 reports
- CADD 21-7391-24Icu Medical, Inc. · Set, administration, intravascular2 recalls77 reports
- CADD 21-7343-24Icu Medical, Inc. · Set, administration, intravascular2 recalls65 reports
- CADD 21-7383-24Icu Medical, Inc. · Set, administration, intravascular2 recalls63 reports
- CADD 21-7333-24Icu Medical, Inc. · Set, administration, intravascular2 recalls24 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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