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U.S. Department of Health and Human Services

Class 2 Device Recall ONQ PainBuster with OnDemand

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  Class 2 Device Recall ONQ PainBuster with OnDemand see related information
Date Initiated by Firm March 27, 2007
Date Posted October 06, 2007
Recall Status1 Terminated 3 on October 07, 2009
Recall Number Z-0057-2008
Recall Event ID 44933
510(K)Number K932740  
Product Classification Infusion pump - Product Code MED
Product ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01, I-Flow Corporation, Lake Forest, CA 92630 U.S.A.
Code Information 6A4171 (exp. MAR 2009), 694133 (exp. FEB 2009), 654920 (exp. OCT 2008), 5A4732 (exp. MAR 2008), 584699 (exp. JAN 2008)
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		 Misassembly: The ON-Q PainBuster PMB01 package may contain a Soaker catheter instead of a Non-Soaker catheter. As a result, the bolus button may remain latched in the down position which may cause the the device to deliver continuously at 7 ml/hr instead of 2 ml/hr.
FDA Determined
Cause 2		 Process control
Action An Important Recall Notification Letter was faxed to affected customers on March 27, 2007. Affected customers were notified of the recall, the reason for recall, and instructed to immediately quarantine any remaining inventory. A Customer Response (and Fax back) form was included with the Recall Notification. Affected customers were requested to return the FAX back form to I-Flow within 48 hours of receipt. Replacement product will be sent out as applicable.
Quantity in Commerce 2,587 units
Distribution Worldwide, USA and Australia
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 = MED and Original Applicant = BLOCK MEDICAL, INC.
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