Merit Medical Systems, Inc. Prelude Pro Sheath Introducer REF/CAT No.: PRO-6F-11-035 Prelude PRO SHEATH INTRODUCER 6F 11
FDA device recall Z-0519-2010 · 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
- DRE
- Quantity affected
- 5 Sheath Introducers
- 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 |
|---|---|---|
| MERIT PRELUDE SHEATH INTRODUCER (K050962) | Merit Medical Systems, Inc. | 2005-05-06 |