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U.S. Department of Health and Human Services

Class 2 Device Recall IFlow ONQ with SelectAFlow Pumps

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 Class 2 Recall
IFlow ONQ with SelectAFlow Pumps
see related information
Date Posted July 28, 2011
Recall Status1 Terminated on August 09, 2012
Recall Number Z-2860-2011
Recall Event ID 59148
Premarket Notification
510(K) Number
K063530 
Product Classification Pump, Infusion, Elastomeric - Product Code MEB
Product I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. It is a controller that allows the user to regulate the amount of medication that is dispensed.
Code Information Model Numbers: CB004, CB005, CB006, CB6004, CB6007, P100X2-14, P200X2-14, P270X1-7, P400X2-14, P400X1-7+5/60, P400X2-14+5/30, P600X2-14, P600X1-7D, and SAF01. Part Numbers: 5001481,5001521,5001651,5001771,5001780,5001788,5001799, 5001807,5001808,5001809,5001810,5001811,5001830, and 5001831. Specific lot numbers: 122215, 132435, 132464, 932165, and 962434. Also, all lot numbers that begin with: 98 (except 982631 and 982645), 99, 9A (except 9A2913), 9B, 9C, 01, 02, 03, 04, 05, 06, 07, 08, 09, 0A, 0B, and 0C (except 0C2949 and 0C2950).
Recalling Firm/
Manufacturer
I-Flow Corporation
20202 Windrow Dr
Lake Forest, California 92630-8152
For Additional Information Contact Thomas Kozma, PhD
770-587-8393
Manufacturer Reason
for Recall
The recall was initiated because I Flow became aware that a small percentage of ON-Q Pump with Select A Flow may develop a minor leak with a flow rate controller. There may be consequences for the patient, such as under delivery of pain medication or the need to prematurely remove the pump, which would result in loss of the pain treatment provided by the pump.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action I-Flow Corporation sent an "Important Voluntary Market Withdrawal Notice" dated May 12, 2011 to all affected customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to quarantine and return all impacted products within their facilities. Customers were instructed to respond with in 5 days of receiving the Market Withdrawal Notice and fax it to (949) 206-2663. Customers with additional questions, were instructed to call I-Flow Customer service at (800) 448-3569 (8-5pm, Pacific Standard time) or I-Flow 24 hour technical support line (800) 444-2728.
Quantity in Commerce 96,892 units total (95,637 units in US)
Distribution Nationwide (USA) Distribution and worldwide to: Australia, Canada, Cyprus, Italy, Germany, Finland, Greece, Israel, South Africa, Sweden, UAE, and UK.
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 = MEB and Original Applicant = I-FLOW CORP.
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