| | Class 1 Recall
ON-Q pump with ONDEMAND bolus button |  |
| Date Posted |
August 28, 2012 |
| Recall Number |
Z-2253-2012 |
| 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.
|
Recalling Firm/
Manufacturer |
I-Flow Corporation
20202 Windrow Dr
Lake Forest, California 92630-8152 |
| For Additional Information Contact |
Christopher Barys
949-206-2604
|
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.
|
| 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. |
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