Class 1 Device Recall ONQ pump with ONDEMAND bolus button

• Date Initiated by Firm: May 08, 2012
• Date Posted: August 28, 2012
• Recall Status: Terminated on April 25, 2013
• Recall Number: Z-2253-2012
• Recall Event ID: 62769
• 510(K)Number: K023318
• Product Classification: Pump, infusion, elastomeric - Product Code MEB
• Product: ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves.
• Code Information: Products having a 10-digit Lot # that is greater than 0200521454 (i.e. 0200521455 and greater) are not impacted by this recall.
• FEI Number: 3011270181
• Recalling Firm/ Manufacturer: I-Flow Corporation; 20202 Windrow Dr; Lake Forest CA 92630-8152
• For Additional Information Contact: Christopher Barys; 949-206-2604
• Manufacturer Reason for Recall: It was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. As a result, the patient may receive continuous infusion at a rate greater than expected.
• FDA Determined Cause: Device Design
• Action: An Important Voluntary Recall Notice letter dated 5/8/12 was sent to all their customers who purchased the ON-Q pump with ONDEMAND bolus button. The letter provided customers with the problem indicated and the actions to be taken. Customers were instructed to complete and sign the attached Recall Response Form and fax to (920)969-4565 or scan and email to IflowProductInquiry@kcc.com. Once I-Flow receives the completed FAX BACK form, an I-Flow Customer Service Representative will immediately contact the customers to provide instructions on product return and credit. Customers with questions regarding the recall letter, were instructed to contact I-Flow Customer Service between 8am to 5pm (PST) at (800) 443-3569. Or customers can contact I-Flow 24 hour Technical Support line at (800) 444-2728.
• Quantity in Commerce: 80,646 units total (65,926 units in US)
• Distribution: Worldwide Distribution -- USA, Canada, Australia, the EU (Germany), United Arab Emirates, and Cyprus.
• 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