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U.S. Department of Health and Human Services

Class 2 Device Recall CADD High Volume Administration Set

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  Class 2 Device Recall CADD High Volume Administration Set see related information
Date Initiated by Firm May 15, 2017
Create Date October 11, 2018
Recall Status1 Terminated 3 on April 04, 2018
Recall Number Z-2589-2017
Recall Event ID 77284
510(K)Number K031361  
Product Classification Set, administration, intravascular - Product Code FPA
Product CADD¿ High Volume Administration Set with FlowStop, 21-7381-24.

Product Usage:
The CADD¿ High-Volume Administration set is designed for use with the CADD¿ Prizm pump to allow fluid deliver from an IV bag.
Code Information Lot#:26X035
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
Manufacturer Reason
for Recall		 One lot of CADD¿ High Volume Administration sets, part number 21-7381-24, lot number 26X035, incorrectly contained the IFU insert for part number 21-7357-24.
FDA Determined
Cause 2		 Process control
Action Consignees were sent on 5/15/2017 a Smiths Medical "Urgent Medical device Recall Notice" dated May 15, 2017. The letter described the Affected Devices, Reason for Recall, Risk to Health, & Instructions to Customers. Advised consignees to complete and send the Urgent Medical Device Recall Response Form to smithsmedical7903@stericycle.com within 10 calendar days of receipt of this Notice.If you have distributed affected devices to your customers, immediately notify your customers of this Recall and retrieve all affected devices. For questions contact Stericycle via email at: smithsmedical7903@stericycle.com.
Quantity in Commerce 7,035
Distribution US Nationwide in the states of PA, TN, NV, CA, MD, AR, CA, VA, OH, MN, NY, VT, NY.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FPA and Original Applicant = DELTEC, INC.
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