Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medical ASD, Inc, Dublin, Ohio 430
FDA device recall Z-0695-2008 · posted 2008-01-31 · Terminated
Recall details
- Recalling firm
- Smiths Medical Asd Inc
- 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
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- CBT
- Quantity affected
- 1440 units
- Distribution
- Nationwide including the states of CA, DC, IL, IN, MD, MN, NC, NE, SC, and TN and Puerto Rico.
- Date initiated
- 2007-11-21
- Date posted
- 2008-01-31
- Date terminated
- 2010-09-30
- Location
- Dublin, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTERIAL BLOOD SAMPLING KIT (K902771) | Medex, Inc. | 1990-11-05 |