Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medical ASD, Inc, Dublin, Ohio 43016
FDA Recall Z-0695-2008 · Posted 2008-01-31
Recalling FirmSmiths Medical Asd Inc
Recall StatusTerminated
Product CodeCBT
Date Initiated2007-11-21
Date Terminated2010-09-30
Product Quantity1440 units
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
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Nationwide including the states of CA, DC, IL, IN, MD, MN, NC, NE, SC, and TN and Puerto Rico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.