Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO, Merit Medical Syst
FDA device recall Z-1731-2010 · posted 2010-05-28 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Marker bands on angiographic catheters may not be properly attached, allowing movement of the bands.
- Action taken
- Merit Medical Systems, Inc. began notifying sales representatives beginning May 5, 2010 via phone and instructed to contact all of their affected accounts. All affected product was to be returned to the firm. For further information, contact Merit Medical at 1-713-757-5067 or 1-801-208-4468.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 96 units
- Distribution
- Nationwide Distribution -- GA, IL, MO, NY, PA and WI.
- Date initiated
- 2010-05-05
- Date posted
- 2010-05-28
- Date terminated
- 2010-06-01
- 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 |
|---|---|---|
| MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT (K000659) | Merit Medical Systems, Inc. | 2000-03-29 |