Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4033, Smiths Medical ASD, Inc, Dublin, Ohio 43016
This recall has been terminated (originally issued January 31, 2008).
- Company
- Smiths Medical Asd Inc
- Recall Initiated
- November 21, 2007
- Posted
- January 31, 2008
- Terminated
- September 30, 2010
- Recall Number
- Z-0696-2008
- Quantity
- 250 units
- Firm Location
- Dublin, OH
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide including the states of CA, DC, IL, IN, MD, MN, NC, NE, SC, and TN and Puerto Rico.
Lot / Code Info
Lot Numbers: 1189082, 1231444, 1178100, and 1225588.
Root Cause
Packaging process control
Action Taken
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.