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U.S. Department of Health and Human Services

Class 2 Device Recall SmartSite Low Sorbing Infusion Set

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  Class 2 Device Recall SmartSite Low Sorbing Infusion Set see related information
Date Initiated by Firm June 17, 2014
Date Posted July 09, 2014
Recall Status1 Terminated 3 on September 20, 2016
Recall Number Z-2025-2014
Recall Event ID 68608
510(K)Number K944320  
Product Classification Set, administration, intravascular - Product Code FPA
Product SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A


14035457
14035485
14046894
14035458
Code Information Lot No. 14035485 14046894 14035458 14035457 
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information Contact
858-617-4000
Manufacturer Reason
for Recall		 CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that the set should not be used with blood administration due to the potential for occluding the 15 micron filter in the drip c
FDA Determined
Cause 2		 Labeling Change Control
Action A recall letter is dated 6/25/14 and will be sent out to customers who purchased the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that the set should not be used with blood administration due to the potential for occluding the 15 micron filter in the drip chamber. The letter informs the customers of the problems identified, potential risk, and actions to be taken. Customers are instructed to promptly complete and return the enclosed mandatory Customer Response Card to acknowledge the receipt of this communication and to expedite the corrective action process.
Quantity in Commerce 5,600 units
Distribution Distributed in the states of FL, NM, WA, WI, and TX.
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 = IMED CORP.
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