Date Initiated by Firm |
February 13, 2003 |
Date Posted |
March 06, 2003 |
Recall Status1 |
Terminated 3 on March 07, 2003 |
Recall Number |
Z-0620-03 |
Recall Event ID |
25605 |
510(K)Number |
K973230 K883718 K913682 K934123
|
Product Classification |
Catheter, Intravascular, Diagnostic - Product Code DQO
|
Product |
Custom Angiographic Kit. |
Code Information |
Model Number: K04-00278/A. Lot Numbers: A253131. |
Recalling Firm/ Manufacturer |
Merit Medical Systems, Inc 1600 West Merit Parkway South Jordan UT 84095
|
Manufacturer Reason for Recall |
A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by phone and FAX on 2/12/2003. |
Quantity in Commerce |
250 kits |
Distribution |
FL and Japan. |
Total Product Life Cycle |
TPLC Device Report
|
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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 = DQO and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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