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.
This recall has been terminated (originally issued October 6, 2007).
- Company
- I-Flow Corporation
- Recall Initiated
- March 27, 2007
- Posted
- October 6, 2007
- Terminated
- October 7, 2009
- Recall Number
- Z-0057-2008
- Quantity
- 2,587 units
- Firm Location
- Lake Forest, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide, USA and Australia
Lot / Code Info
6A4171 (exp. MAR 2009), 694133 (exp. FEB 2009), 654920 (exp. OCT 2008), 5A4732 (exp. MAR 2008), 584699 (exp. JAN 2008)
Root 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.