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U.S. Department of Health and Human Services

Class 2 Device Recall Alaris

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 Class 2 Recall
Alaris
see related information
Date Posted August 03, 2007
Recall Status1 Open
Recall Number Z-1078-2007
Recall Event ID 38215
Premarket Notification
510(K) Number
K872764 
Product Classification Pump, Infusion - Product Code FRN
Product Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris Medical Systems, Lot Number 07036013
Code Information Lot Number 07036013
Recalling Firm/
Manufacturer
Cardinal Health 303 Inc DBA Alaris Products
10221 Wateridge Cir
San Diego, California 92121-2733
For Additional Information Contact Stacy L. Lewis
858-458-7830
Manufacturer Reason
for Recall
The sterility of the product may be compromised as the packaging used for the sterility barrier was not designed for the sterility process used by the firm.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Recall Notification consists of a phone call and Recall Notification letters to consignees (distributors) as well as direct customers. On June 5, 2007, Cardinal Health began calling customers and distributors to inform them of a recall affecting IV Administration Set, Model C20014, Lot Number 07036013 (Low Sorbing Extension Set). A follow-up Recall Notification Letter was sent on June 11, 2007. The customers and distributors were notified by registered return receipt mail. For direct customers, letters were sent directly to the point of contact at the hospital. For distributors, they were sent multiple copies of the Recall Notification; along with a cover letter outlining their responsibilities to complete the Recall plan and notify their customers as requested.
Quantity in Commerce 4,248 sets (59 boxes)
Distribution Nationwide.
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 = FRN and Original Applicant = Y
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