Date Initiated by Firm | October 30, 2003 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on November 25, 2003 |
Recall Number | Z-0152-04 |
Recall Event ID |
27697 |
Product Classification |
Set, Administration, Intravascular - Product Code FPA
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Product | 100 inch (254 cm) 15 Drop Administration Set with FlowSafe Flow Controller and Max Y Connector, 50 per box. Product No. MFS102 |
Code Information |
Lots D316302 and D323912. |
Recalling Firm/ Manufacturer |
Maximus Medical Products Inc 3183 Airway Ave Bldg E Costa Mesa CA 92626
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For Additional Information Contact | Rita Bennett 800-780-0012 Ext. 237 |
Manufacturer Reason for Recall | Mislabeled with wrong drop size drip chamber specification. |
FDA Determined Cause 2 | Other |
Action | The firm called and sent fax recall letters on or about 10/30/2003. Labels were shipped and applied to stock in question. Recall is complete. |
Quantity in Commerce | 63 cases, 50 per case. |
Distribution | CO, PA, |
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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