Clearlink System Continu-Flo Solution Set, 10 drops/mL, 113'', 2 Luer Activated Valves, Male Luer Lock Adapter, catalog
FDA device recall Z-1156-03 · posted 2003-08-21 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Action taken
- Recalled by letter dated 7/16/03. The accounts were informed of the potential for leaks in the set tubing, and asked to inspect their inventory for the affected product codes and lots, segregate any affected products found and discard them according to local procedures. The customers will receive credit for the discarded affected product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 887,483 units
- Distribution
- Nationwide, Mexico, Canada, Columbia, Australia, New Zealand and Taiwan
- Date initiated
- 2003-07-16
- Date posted
- 2003-08-21
- Date terminated
- 2004-06-29
- 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 |
|---|---|---|
| SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE (K003225) | Baxter Healthcare Corp | 2000-10-19 |