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Class 3 Device Recall AddOn Kids Kit |
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Date Initiated by Firm |
November 21, 2007 |
Date Posted |
January 31, 2008 |
Recall Status1 |
Terminated 3 on September 30, 2010 |
Recall Number |
Z-0696-2008 |
Recall Event ID |
45889 |
510(K)Number |
K902771
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Product Classification |
Blood Sampling System, - Product Code CBT
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Product |
Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4033, 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
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For Additional Information Contact |
614-889-2220
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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
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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 |
250 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
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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.
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510(K) Database |
510(K)s with Product Code = CBT and Original Applicant = MEDEX, INC.
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