StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model number 2N9205K.
FDA device recall Z-0925-03 · posted 2003-06-12 · Terminated
Recall details
- Recalling firm
- Venetec Intl Inc
- Reason for recall
- Set tubing disconnected from the male luer lock during use on patients. Misassembled.
- Action taken
- A recall letter was sent to the distributor who then sent thier own letters to the affected hospitals. Hospitals were reached on or about May 14, 2003 whereas the distributor was contacted by telephone and letter on or about May 12, 2003. It was verbally agreed that the distributor would subrecall the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 3150 units
- Distribution
- One distributor sent the product to 6 hospitals in the states of CT, IN, PA, TN.
- Date initiated
- 2003-05-12
- Date posted
- 2003-06-12
- Date terminated
- 2003-10-14
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES (K980992) | Venetec Intl., Inc. | 1998-05-28 |