Z-1767-2017Class II

CADD Administration Set, 21-7339-24, Rx Only, Sterile EO

Name: Z-1767-2017 CADD Administration Set, 21-7339-24, Rx Only, Sterile EO
Creator: Smiths Medical ASD Inc.
Published: 2017-03-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-03-17 / Terminated / root cause: packaging

FDA source

Smiths Medical ASD Inc. began a recall of CADD Administration Set, 21-7339-24, Rx Only, Sterile EO on 2017-03-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1767-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-17
Posted: 2017-03-30
Terminated: 2019-07-03
Recalling firm: Abbott Medical
Product: CADD Administration Set, 21-7339-24, Rx Only, Sterile EO.
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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.
Quantity in commerce: 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
Product codes and lots: 46X817, 46X829, 46X899, 46X828, 46X896, 46X990, 46X831, 46X897, 46X1001.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1767-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1767-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-10

Product code FPA

K040636Class IICadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and Extension SetSmiths Medical MD, Inc. / cleared 2004-05-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)