Fluid Administration Set, Custom Kit, REF: K09-05785FP, Caution: For manufacturing, processing or repacking., Merit Medi
FDA device recall Z-1801-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Convenience kits may contain non-filtered drip chambers
- Action taken
- An Urgent Product Recall Notice was issued on 04/08/2008 requiring that all affected product be returned to Merit. A response form was included with the notification letter.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 55 kits
- Distribution
- Class II Recall - Nationwide Distribution --- including states of IL, SC, VA, WI.
- Date initiated
- 2008-04-08
- Date posted
- 2008-09-11
- Date terminated
- 2009-04-06
- Location
- South Jordan, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MERIT ADMINISTRATION SET (K915678) | Merit Medical Systems, Inc. | 1992-07-30 |