Date Initiated by Firm |
November 08, 2013 |
Date Posted |
December 03, 2013 |
Recall Status1 |
Terminated 3 on April 17, 2014 |
Recall Number |
Z-0435-2014 |
Recall Event ID |
66758 |
510(K)Number |
K944320
|
Product Classification |
Intravascular Adminstration Set - Product Code FPA
|
Product |
VersaSafe Extension Set, Model No. 21000M-007 |
Code Information |
Lot No. 13066550 |
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 VersaSafe Extension Intravascular
Administration Set because it may have excessive adhesive
which will prevent the male spin collar to operate as intended.
|
FDA Determined Cause 2 |
Employee error |
Action |
A customer letter and a distributor letter will be distributed on 11/8/13 to all customers who purchased the VersaSafe Extension Set, Model 21000M-07, Lot Number 13066550. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card. |
Quantity in Commerce |
3500 units |
Distribution |
Nationwide Distribution. |
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.
|