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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Product Detail

Product Description 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.
Recall Number Z-2253-2012
Classification Class I
Code Info Products having a 10-digit Lot # that is greater than 0200521454 (i.e. 0200521455 and greater) are not impacted by this recall.
Product Distributed Qty 80,646 units total (65,926 units in US)
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.

Event Detail

Event Id 62769
Product Type Devices
Status Ongoing
Recalling Firm I-Flow Corporation
City Lake Forest
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution -- USA, Canada, Australia, the EU (Germany), United Arab Emirates, and Cyprus.