Class 2 Device Recall Angiographic Convenience Kit

• Date Initiated by Firm: February 13, 2003
• Date Posted: March 06, 2003
• Recall Status: Terminated on March 07, 2003
• Recall Number: Z-0621-03
• Recall Event ID: 25605
• 510(K)Number: K883718 K913682 K934123 K973230
• Product Classification: Catheter, Intravascular, Diagnostic - Product Code DQO
• Product: Custom Angiographic Kit
• Code Information: Model Number: K08-MP5130. Lot Numbers: A146066, A188604.
• 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: Other
• Action: Consignees were notified by phone and FAX on 2/12/2003.
• Quantity in Commerce: 100 kits.
• Distribution: FL and Japan.
• 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 = DQO