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U.S. Department of Health and Human Services

Class 2 Device Recall CADD BlueStriped Administration Set

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 Class 2 Device Recall CADD BlueStriped Administration Setsee related information
Date Initiated by FirmDecember 09, 2016
Create DateJuly 24, 2017
Recall Status1 Terminated 3 on December 14, 2017
Recall NumberZ-2759-2017
Recall Event ID 77791
510(K)NumberK933390 
Product Classification IV administration set - Product Code FPA
ProductSmiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
Code Information 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
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
Manufacturer 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.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionCustomers 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
Quantity in Commerce641,070 units
DistributionCanada only
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FPA
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