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U.S. Department of Health and Human Services

Class 2 Device Recall ONQ PainBuster

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  Class 2 Device Recall ONQ PainBuster see related information
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
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
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
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.
510(K) Database 510(K)s with Product Code = MEB and Original Applicant = BLOCK MEDICAL, INC.
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