Baxter Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock Extension Set, 10 drops/mL, product code
FDA device recall Z-0943-05 · posted 2005-06-30 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- There is an unsecure connection between the male Luer and the stopcock on the I.V. extension set.
- Action taken
- Recall letters dated 4/21/05 were sent to the direct accounts via first class mail on the same date to the attention of the Director of Materials Management. The accounts were informed of the reports of an unsecure connection between the male luer and the stopcock due to silicone on the male luer tip, and were requested to examine their inventory for the affected lots of product, and call Baxter Healthcare Center for Service at 1-888-229-001 to return the affected product for credit.
- Root cause
- Other
- Status
- Terminated
- Product code
- FMG
- Quantity affected
- 107,832 sets
- Distribution
- Nationwide and internationally to American Samoa and Venezuela.
- Date initiated
- 2005-04-21
- Date posted
- 2005-06-30
- Date terminated
- 2006-07-19
- Location
- Round Lake, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELCAM STOPCOCKS AND MANIFOLDS (K022895) | Medical Device Consultants, Inc. | 2002-10-18 |