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Class 2 Device Recall CareFusion Gravity Set |
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Date Initiated by Firm |
August 30, 2013 |
Date Posted |
September 26, 2013 |
Recall Status1 |
Terminated 3 on December 26, 2013 |
Recall Number |
Z-2281-2013 |
Recall Event ID |
66152 |
510(K)Number |
K820278
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Product Classification |
Set, administration, intravascular - Product Code FPA
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Product |
CareFusion Gravity Set, Model #44000-07
The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a check valve, injection ports, 4-way stopcock, anti-siphon valve, roller clamp and tubing. |
Code Information |
Lot Numbers: 12086930, 12106215, 13016408, 13016834, 13025446, and 13025672. |
Recalling Firm/ Manufacturer |
CareFusion 303, Inc. 10020 Pacific Mesa Blvd San Diego CA 92121-4386
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For Additional Information Contact |
858-617-4000
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Manufacturer Reason for Recall |
CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with
a 5 year expiration instead of three (3) years.
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FDA Determined Cause 2 |
Employee error |
Action |
CareFusion sent an Urgent Medical Device Recall Notification letter dated August 30, 2013, to all affected customers to inform them that CareFusion is recalling the Gravity Set, Model 44000-07, Lot Numbers 12086930, 12106215, 13016408, 13016834, 13025446 and 13025672 as a result of an incorrect expiration date. The letter informs the customers of the problem identified, issues, potential risk, and the immediate actions to be taken. Customers are instructed to complete the customer response form and return the form to CareFusion. Customers are instructed to return recalled products directly to distributors. A distributor letter will also be sent to distributors on August 30, 2013, to inform them of the problems identified and the actions to be taken. Distributors are instructed to contact the Customer Support Team, return customer response form, and if they have questions then they are instructed to contact the CareFusion Support Center at 1-800-562-6018.
For questions regarding this recall call 858-617-4000. |
Quantity in Commerce |
2,850 units |
Distribution |
IL |
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 and Original Applicant = Y
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