Recall Z-0695-2008 ยท CBT Arterial Blood Sampling Kit
Smiths Medical Asd Inc
Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medical ASD, Inc, Dublin, Ohio 43016
| Date | Jan 31, 2008 (initiated Nov 21, 2007) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 | 1440 units |
| Distribution | Nationwide including the states of CA, DC, IL, IN, MD, MN, NC, NE, SC, and TN and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902771 | ARTERIAL BLOOD SAMPLING KIT Medex, Inc., Nov 5, 1990 |