Smiths Medical Asd Inc Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medical ASD, Inc, Dublin, Ohio 43016 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medical ASD, Inc, Dublin, Ohio 43016
Brand
Smiths Medical Asd Inc
Lot Codes / Batch Numbers
Lot Numbers: 1189082, 1231444, 1178100, and 1225588.
Products Sold
Lot Numbers: 1189082, 1231444, 1178100, and 1225588.
Smiths Medical Asd Inc is recalling Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medical ASD, due to Misbranded; The product codes are labeled incorrectly with a green promotional label for "New split septum sampling site. Only use needle-free access . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026