—#157885

Product

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

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K933390
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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 smithsmedical6185@stericycle.com

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: Canada only

Timeline

Recall initiated: 2016-12-09
Terminated: 2017-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157885. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.