A Class I recall has been issued for the I-Flow ON-Q Pump, the U.S. Food & Drug Administration (FDA) just announced. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The agency advised healthcare professionals that the I-Flow ON-Q Pump with ONDEMAND Bolus Button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowest most position. When this happens, said the FDA, the patient may receive continuous infusion at a rate greater than expected, resulting in serious adverse health consequences, including death. A listing of the affected product, part, expiration, and lot numbers is detailed in the FDA’s recall notice, which can be accessed here.
The On-Q pump with ONDEMAND bolus button is used for continuous and intermittent delivery of medicines—local anesthetics or narcotics—to or around surgical wound sites and/or to nearby nerves for pre-, perio, and post (before during, and after) operative regional anesthetic and pain management.
The I-Flow ON-Q pump with ONDEMAND bolus button was manufactured from October 18, 2002 through April 30, 2012 and distributed from May 3, 2010 through May 1, 2012. The recalling firm is I-Flow Corporation, which is located at 20202 Windrow Drive, Lake Forest, California, 92630
On May 8, 2012, the firm sent an Important Voluntary Recall Notice to its customers who purchased the ON-Q pump with ONDEMAND bolus button. Customers are advised to identify and quarantine all the recalled products within their inventory and to not use those products. Within five days of receiving the Important Voluntary Recall Notice, customers were asked to complete and sign the attached Recall Response Form and fax it to 1.920.969.4565 or scan and email it to IflowProductInquiry@kcc.com. Upon receipt of the form, an I-Flow Customer Service Representative will contact customers to provide instructions on product return and credit.
Customers with questions regarding the recall are instructed to contact I-Flow Customer Service between 8:00 a.m. to 5:00 p.m. Pacific Standard Time (PST), toll-free at 1.800.448.3569. Customers may contact the I-Flow 24-hour Technical Support line, toll-free, at 1.800.444.2728.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online at www.fda.gov/MedWatch/report.htm or download the form at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm or call 1.800.332.1088 to request a reporting form, then complete and return the form to the address on the pre-addressed form, or submit by fax to 1.800.FDA.0178