Class I Medical Device Recall: I-Flow ON-Q Pump with ONDEMAND Bolus Button
Recall Class: Class I
Date Recall Initiated: May 8, 2012
Product: ON-Q Pump with ONDEMAND Bolus Button
|Product Name||ON-Q pump with ONDEMAND bolus button|
|Part Number||101347100, 101347300, 101347400, 101360200,|
101368400, 101368600, 101368700, 102987000,
102987200, 102987300, 103161800, 103534300,
5001438, 5001470, 5001651, 5001780, 5001808,
5001809, 5001812, 7000180, 7000181, 7000182,
|Expiration Date||All model and part numbers referenced here have an expiration date of 2014-04 or earlier.|
|Lot Number(s)||Products having a 1O-digit lot number that is greater than 0200521454, such as 0200521455 and greater, are not impacted by this recall.|
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
Use: The On-Q pump with ONDEMAND bolus button is used for continuous and intermittent delivery of medicines (such as local anesthetics or narcotics) to or around surgical wound sites and/or to nearby nerves for pre-operative, during the procedure/surgery (perioperative), and for post-operative regional anesthetic and pain management.
20202 Windrow Drive
Lake Forest, California 92630
Reason for Recall:
The firm determined that the ON-Q pumps 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 occurs, the patient may receive continuous infusion at a rate greater than expected. As a result, this product may cause serious adverse health consequences, including death.
Public Contact: See below for firm contact information.
FDA District: Los Angeles
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. The letter stated the problem and the actions to be taken.
To expedite the process, customers are instructed to do the following:
- Identify all affected products within your inventory.
- Do Not Use and Quarantine the affected products.
- Within 5 days of receiving this notice, 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 am to 5 pm Pacific Standard Time at 1-800-448-3569. Or customers can contact the I-Flow 24-hour Technical Support line at 1-800-444-2728.
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.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.