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 |
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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.
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510(K) Database | 510(K)s with Product Code = FPA
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