| Class 2 Device Recall Dilator for percutaneous catheterization. |  |
Date Initiated by Firm | July 20, 2004 |
Date Posted | August 04, 2004 |
Recall Status1 |
Terminated 3 on January 21, 2005 |
Recall Number | Z-1309-04 |
Recall Event ID |
29651 |
510(K)Number | K031691 |
Product Classification |
Dilator, Vessel, For Percutaneous Catheterization - Product Code DRE
|
Product | Merit MAK Mini Access Kit, 4 French (1.3mm) |
Code Information |
Catalog Number MAK401, Lot Numbers: G322819, M9337627, MR314384, MR314386, MR317164, MR320056. |
Recalling Firm/ Manufacturer |
Merit Medical Systems, Inc 1600 Merit Pkwy South Jordan UT 84095-2416
|
For Additional Information Contact | 801-253-1600 |
Manufacturer 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. |
FDA Determined Cause 2 | Other |
Action | Consignees were notified by phone and letter on 7/20/2004. |
Quantity in Commerce | 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 Emirates. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = DRE
|
|
|
|