| Class 2 Device Recall SmartSite | |
Date Initiated by Firm | August 30, 2013 |
Date Posted | September 26, 2013 |
Recall Status1 |
Terminated 3 on April 16, 2014 |
Recall Number | Z-2285-2013 |
Recall Event ID |
66151 |
510(K)Number | K944320 |
Product Classification |
Set, administration, intravascular - Product Code FPA
|
Product | SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set. |
Code Information |
Lot Numbers 13015883 and 13025342. |
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, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber. |
FDA Determined Cause 2 | Process design |
Action | A customer letter dated August 30, 2013 will be sent to customers to inform them that CareFusion is recalling the SmartSite Low Sorbing Infusion Set Models 10015048, Lot Numbers 130153883 and 13025342 as a result of a potential for separation at the tubing sleeve below the drip chamber.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 8/30/13 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 they are instructed to contact the CareFusion Support Center at 1-800-562-6018 with any questions. . |
Quantity in Commerce | 15860 units |
Distribution | Nationwide in US: PA, OK, TX, FL, NC, CA, IN, WI |
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
|
|
|
|