7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 4CM Advance Needle; and 0.018" X 40CM; REF No.:
FDA device recall Z-1410-2009 · posted 2009-06-10 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- External tubing may separate during use, allowing blood loss.
- Action taken
- All of Merit's US sales representatives and distributors were notified by Prelude Short Sheath Introducer - Product Recall letter on 4/14/2009. They were instructed to promptly contact their customers. Customers were instructed to isolate, remove from inventory, and return all affected inventory. A Product Retrieval Form was to be returned to Merit. Further information is available at 801-316-4998 or 801-208-4344.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 569 units
- Distribution
- Worldwide Distribution -- USA, including states of CA, CO, GA, IL, MO, OK, and OR and countries of Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, Japan, Latvia, Lithuania, Netherlands,
- Date initiated
- 2009-04-14
- Date posted
- 2009-06-10
- Date terminated
- 2010-02-09
- 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 |