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U.S. Department of Health and Human Services

Class 2 Device Recall VersaSafe Extension Set

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 Class 2 Recall
VersaSafe Extension Set
see related information
Date Posted December 03, 2013
Recall Status1 Terminated on April 17, 2014
Recall Number Z-0435-2014
Recall Event ID 66758
Premarket Notification
510(K) Number
K944320 
Product Classification Set, Administration, Intravascular - 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, California 92121-4386
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
TRAINING: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = IMED CORP.
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