ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Refer

FDA device recall Z-2253-2012 · posted 2012-08-28 · Terminated

Recall details

Recalling firm

I-Flow Corporation

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 taken

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.

Root cause

Device Design

Status

Terminated

Product code

MEB

Quantity affected

80,646 units total (65,926 units in US)

Distribution

Worldwide Distribution -- USA, Canada, Australia, the EU (Germany), United Arab Emirates, and Cyprus.

Date initiated

2012-05-08

Date posted

2012-08-28

Date terminated

2013-04-25

Location

Lake Forest, CA

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