Z-2759-2017Class II

Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide

Name: Z-2759-2017 Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide
Creator: Smiths Medical ASD Inc.
Published: 2016-12-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2016-12-09 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD Inc. began a recall of Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide on 2016-12-09. FDA classified it as Class II and gives the reason as "The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2759-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-09
Posted: 2017-07-24
Terminated: 2017-12-14
Recalling firm: Abbott Medical
Product: Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
Product code: FPA Set, Administration, Intravascular
Reason for recall: The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada.
Root cause tag: labeling and UDI
FDA root cause: Unknown/Undetermined by firm
Action: Customers were sent an Urgent Medical Device Safety Notice, dated 12/9/2016. The letter identified affected product and stated the reason for recall. The letter also provided a list of devices that each consignee ordered, along with the date of manufacture and associated expiration date. Customers were asked to locate devices and compare to the list and determine if affected devices are within expiration date. If the device is expired customers are to dispose of them per their procedures for dealing with expired product. If devices are not expired, they may continue to use them through the expiration date. A response form was asked to be returned within 10 day s of receipt of the letter. Questions can be directed to [email protected]
Quantity in commerce: 641,070 units
Distribution: Canada only
Product codes and lots: Lot No.: 010X47, 025X47, 064X46, 079X48, 094X46, 103X46, 108X49, 155X40, 170X47, 173X47, 187X49, 193X45, 208X40, 208X45, 217X46, 224X46, 230X44, 241X40, 268X40, 286X40, 41X065, 41X099, 41X173, 41X221, 41X284, 41X302, 41X366, 41X399, 41X506, 42X047, 42X154, 42X238, 42X266, 42X302, 42X393, 42X505, 431X40, 43X013, 43X099, 43X125, 43X166, 42X259, 43X298, 43X357, 43X424, 43X467, 43X527, 43X549, 44X053, 44X110, 44X169, 44X197, 44X272, 44X359, 44X388, 44X442, 44X493, 44X547, 44X567, 44X596, 44X682, 44X704, 44X714, 45X074, 45X091, 45X142, 45X234, 45X246, 45X260, 45X346, 45X424, 45X538, 46X023, 46X141, 46X181, 46X228, 46X255, 46X429, 46X430, 46X475, 46X490, 46X543, 46X631

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2759-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2759-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-24

Product code FPA

K933390Class IIRemote Reservoir Adapter(tm) Cassette with BagPharmacia Deltec, Inc. / cleared 1994-02-09

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)