Date Initiated by Firm | April 15, 2008 |
Date Posted | September 04, 2008 |
Recall Status1 |
Terminated 3 on September 03, 2008 |
Recall Number | Z-1700-2008 |
Recall Event ID |
47891 |
Product Classification |
Convenience Kit - Product Code DQO
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Product | Custom Kit, Custom Angiographic Kit, REF: K05-YS1032, Revision A, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. |
Code Information |
Lot Number F603790 |
Recalling Firm/ Manufacturer |
Merit Medical Systems, Inc. 1600 Merit Pkwy South Jordan UT 84095-2416
|
For Additional Information Contact | 801-208-4408 Ext. 349 |
Manufacturer Reason for Recall | Convenience kits may be non-sterile due to inadequate package sealing. |
FDA Determined Cause 2 | Process control |
Action | Consignees were notified by letter (Urgent Product Recall) on 04/15/2008 and instructed to quarantine all affected kits for return to Merit. A Product Retrieval Form was included to be completed by the site representative. Please contact Greg Turner at 1-801-316-4998 or Jon Davis at 801-208-4497. |
Quantity in Commerce | 10 kits |
Distribution | MO. Foreign distribution to Japan. No military or government distribution. |
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.
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