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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 Recall
ONQ PainBuster with OnDemand
see related information
Date Posted October 06, 2007
Recall Status1 Terminated on October 07, 2009
Recall Number Z-0057-2008
Recall Event ID 44933
Premarket Notification
510(K) Number
K932740 
Product Classification Sterilant, Medical Devices - 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, California 92630-8152
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MED and Original Applicant = BLOCK MEDICAL, INC.
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