7F Prelude Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The
FDA device recall Z-1497-2017 · posted 2017-03-24 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude Short Sheath Introducers because the sheath marker tips may detach during use.
- Action taken
- Consignees notified on 2/16/17 to immediately stop using or distributing the affected lots and return them to Merit. For any questions, please contact your Merit Sales Representative or Merit Customer Service at 801.208.4381.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 1,265 total
- Distribution
- Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
- Date initiated
- 2017-02-16
- Date posted
- 2017-03-24
- Date terminated
- 2017-08-08
- 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 |