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U.S. Department of Health and Human Services

Class 3 Device Recall AddOn Kids Kit

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  Class 3 Device Recall AddOn Kids Kit see related information
Date Initiated by Firm November 21, 2007
Date Posted January 31, 2008
Recall Status1 Terminated 3 on September 30, 2010
Recall Number Z-0695-2008
Recall Event ID 45889
510(K)Number K902771  
Product Classification Blood Sampling System, - Product Code CBT
Product Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medical ASD, Inc, Dublin, Ohio 43016
Code Information Lot Numbers: 1189082, 1231444, 1178100, and 1225588.
Recalling Firm/
Manufacturer		 Smiths Medical Asd Inc
6250 Shier Rings Rd
Dublin OH 43016-1270
For Additional Information Contact
614-889-2220
Manufacturer Reason
for Recall		 Misbranded; The product codes are labeled incorrectly with a green promotional label for "New split septum sampling site. Only use needle-free access devices .......", however this product code contains a sampling site which is accessed with a shrouded needle, NOT with a needle-free access device
FDA Determined
Cause 2		 Packaging process control
Action Smiths Medical mailed certified letters (Urgent Product Advisory Notifications) dated November 19, 2007, to all customers that received the affected lot. Firms are instructed to make the field correction (extra label removal) or mail the product back to Smiths for the correction.
Quantity in Commerce 1440 units
Distribution Nationwide including the states of CA, DC, IL, IN, MD, MN, NC, NE, SC, and TN and Puerto Rico.
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 = CBT and Original Applicant = MEDEX, INC.
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