| Class 2 Device Recall Fluid Administration Set | |
Date Initiated by Firm | April 08, 2008 |
Date Posted | September 11, 2008 |
Recall Status1 |
Terminated 3 on April 06, 2009 |
Recall Number | Z-1807-2008 |
Recall Event ID |
47880 |
510(K)Number | K915678 |
Product Classification |
Catheter, biliary, diagnostic - Product Code FPA
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Product | Fluid Administration Set, Custom Kit, REF: K10-01795DP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contrast media and saline from a container to a patient's vascular system. |
Code Information |
Lot Number F604759 |
Recalling Firm/ Manufacturer |
Merit Medical Systems, Inc. 1600 Merit Pkwy South Jordan UT 84095-2416
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For Additional Information Contact | 801-208-4119 |
Manufacturer Reason for Recall | Convenience kits may contain non-filtered drip chambers |
FDA Determined Cause 2 | Mixed-up of materials/components |
Action | An Urgent Product Recall Notice was issued on 04/08/2008 requiring that all affected product be returned to Merit. A response form was included with the notification letter. |
Quantity in Commerce | 64 kits |
Distribution | Class II Recall - Nationwide Distribution --- including states of IL, SC, VA, WI. |
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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510(K) Database | 510(K)s with Product Code = FPA
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