Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH INTRODUCER
FDA device recall Z-0518-2010 · posted 2009-12-14 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Potential sterility breach caused by excessive shipment damage.
- Action taken
- Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 1 Short Sheath
- Distribution
- US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution.
- Date initiated
- 2009-09-29
- Date posted
- 2009-12-14
- Date terminated
- 2009-12-15
- 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 |
|---|---|---|
| PRELUDE SHORT SHEATH INTRODUCER (K082063) | Merit Medical Systems, Inc. | 2008-10-15 |