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U.S. Department of Health and Human Services

Class 2 Device Recall CADD Administration Set

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  Class 2 Device Recall CADD Administration Set see related information
Date Initiated by Firm July 14, 2020
Create Date October 19, 2021
Recall Status1 Terminated 3 on August 04, 2023
Recall Number Z-0148-2022
Recall Event ID 88730
510(K)Number K031361  
Product Classification Set, administration, intravascular - Product Code FPA
Product CADD Administration Sets, Model #21-7346-24
Code Information Lot Numbers: 3750848, 3776357, 3793886, 3766764, 3793887, 3796141, 3776356, 3793888, 3847669
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact Dave Halverson
763-383-3310
Manufacturer Reason
for Recall		 Product may have been manufactured with an air filter assembled in an incorrect orientation.
FDA Determined
Cause 2		 Process control
Action The firm notified its consignees of the issue beginning on 07/14/2020. The firm requested the return of unused product. Distributors were directed to notify their customers. For questions contact Smiths Medical via email at fieldactions@smiths-medical.com.
Quantity in Commerce 371 units
Distribution Canada
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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