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U.S. Department of Health and Human Services

Class 3 Device Recall Standard Drip Administration Set

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 Class 3 Recall
Standard Drip Administration Set
see related information
Date Posted July 30, 2008
Recall Status1 Terminated on September 30, 2010
Recall Number Z-1549-2008
Recall Event ID 47474
Premarket Notification
510(K) Number
Product Classification Set, I.V. Fluid Transfer - Product Code LHI
Product Medex MX821L 72 inch (182.9cm) Administration Sets, Standard Drip, Sterile Single Use, Latex Free device packaged 25 units per case. Used to administer fluids.
Code Information Lot #1217947.
Recalling Firm/
Smiths Medical Asd Inc
6250 Shier Rings Rd
Dublin, Ohio 43016-1270
Manufacturer Reason
for Recall
Misbranded/mispackaged device was distributed. Product labeled to contain 72 inch Standard Drip ( IV) Administration Sets, actually contained 60 inch (IV) administration sets with a' Y' site.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action On 3/24/2008, the firm issued separate URGENT: PRODUCT RECALL NOTIFICATIONs sent via certified mail to their distributor and medical customers. Both recall notifications inform the customers of this labeling error and ask that the customers: 1) check their inventories for the presence of the suspect product; 2) complete and return the attached 'Product Recall Notification Response Form'; and 3) make arrangements to return any unused affected product to the recalling firm in exchange for a credit or replacement product. In addition, the distributors are asked to either provide the recalling firm with a list of their sub-account customers so that Smith Medical can contact the enduser customers and notify them of the recall, or as an alternative measure, the distributor can notify their branches and customers directly, via their own certified letter.
Quantity in Commerce 350 units
Distribution Worldwide Distribution --- USA including states of PA, NJ, IL, MN and ND and country of Canada.
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 = LHI and Original Applicant = MEDEX, INC.