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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
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
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
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

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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