Merit MAK Mini Access Kit, 4 French (1.3mm)
FDA device recall Z-1309-04 · posted 2004-08-04 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc
- Reason for recall
- Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.
- Action taken
- Consignees were notified by phone and letter on 7/20/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- DRE
- Quantity affected
- 1164 kits
- Distribution
- Nationwide, including VA facilities in MA, MI, NY, RI and TX. Argentina, Canada, China, Germany, Italy, Israel, Netherlands, New Zealand, Saudi Arabia, Scotland, Singapore, Thailand, United Arab Emira
- Date initiated
- 2004-07-20
- Date posted
- 2004-08-04
- Date terminated
- 2005-01-21
- 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 MAK (MINI ACCESS KIT) (K031691) | Merit Medical Systems, Inc. | 2003-09-03 |