Recall Z-2253-2012
I-Flow Corporation · initiated May 8, 2012
Class I – dangerous or defective products that could cause serious health problems or death
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.
Codes / lots: Products having a 10-digit Lot # that is greater than 0200521454 (i.e. 0200521455 and greater) are not impacted by this recall.
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 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.
Details
- Recall number
- Z-2253-2012
- Initiated
- May 8, 2012
- Posted by FDA
- August 28, 2012
- Terminated
- April 25, 2013
- Product code
- MEB – Pump, Infusion, Elastomeric
- Quantity
- 80,646 units total (65,926 units in US)
- Distribution
- Worldwide Distribution -- USA, Canada, Australia, the EU (Germany), United Arab Emirates, and Cyprus.
- Recalling firm
- I-Flow Corporation, Lake Forest, CA