Date Initiated by Firm | November 29, 2006 |
Date Posted | January 18, 2007 |
Recall Status1 |
Terminated 3 on December 11, 2009 |
Recall Number | Z-0358-2007 |
Recall Event ID |
36984 |
510(K)Number | K932740 |
Product Classification |
Infusion Pump - Product Code MEB
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Product | I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742 |
Code Information |
Lot numbers: 662449 & 662742 |
Recalling Firm/ Manufacturer |
I-Flow Corporation 20202 Windrow Dr Lake Forest CA 92630-8152
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For Additional Information Contact | Shane Noehre 949-206-2653 |
Manufacturer Reason for Recall | The pump flow rate labeling may not match the package labeling. The label on filter may not match the label on the top of the pump or the package labeling. |
FDA Determined Cause 2 | Other |
Action | A Recall Notification Letter was faxed to affected customers on November 29, 2006. Affected customers were notified of the identity of product subject to recall, the reason for recall, and instructed to quarantine immediately any remaining inventory.
A Customer Response (FAX back) form was included with the Recall Notification Letter (dated November 29, 2006). Affected customers were requested to return the FAX back form to I-Flow within 48 hours of receipt. The fax back form indicates the quantity of remaining product from each lot the customer may have. |
Quantity in Commerce | 3475 |
Distribution | Nationwide |
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 = MEB
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