Recall Z-0057-2008
I-Flow Corporation · initiated March 27, 2007
Product
ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01, I-Flow Corporation, Lake Forest, CA 92630 U.S.A.
Codes / lots: 6A4171 (exp. MAR 2009), 694133 (exp. FEB 2009), 654920 (exp. OCT 2008), 5A4732 (exp. MAR 2008), 584699 (exp. JAN 2008)
Reason for recall
Misassembly: The ON-Q PainBuster PMB01 package may contain a Soaker catheter instead of a Non-Soaker catheter. As a result, the bolus button may remain latched in the down position which may cause the the device to deliver continuously at 7 ml/hr instead of 2 ml/hr.
FDA-determined cause: Process control
Action taken
An Important Recall Notification Letter was faxed to affected customers on March 27, 2007. Affected customers were notified of the recall, the reason for recall, and instructed to immediately quarantine any remaining inventory. A Customer Response (and Fax back) form was included with the Recall Notification. Affected customers were requested to return the FAX back form to I-Flow within 48 hours of receipt. Replacement product will be sent out as applicable.
Details
- Recall number
- Z-0057-2008
- Initiated
- March 27, 2007
- Posted by FDA
- October 6, 2007
- Terminated
- October 7, 2009
- Product code
- MED – Sterilant, Medical Devices
- Quantity
- 2,587 units
- Distribution
- Worldwide, USA and Australia
- Recalling firm
- I-Flow Corporation, Lake Forest, CA