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U.S. Department of Health and Human Services

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 Class 2 Recall
I-Flow ON-Q with Select-A-Flow Pumps		see related information
Date Posted July 28, 2011
Recall Number Z-2860-2011
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
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.
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.
 
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