Merit Medical Systems, Inc. Medallion Syringe REF/CAT No.: MSS111-LB Indicated for use in cardiology and radiology proce
FDA device recall Z-0520-2010 · 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
- FMF
- Quantity affected
- 25 syringes
- 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 |
|---|---|---|
| DISPOSABLE CORONARY CONTROL SYRINGE 12CC (K875196) | Merit Medical Systems, Inc. | 1988-02-11 |