Recall Z-0057-2008 ยท MED Sterilant, Medical Devices
I-Flow Corporation
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.
| Date | Oct 6, 2007 (initiated Mar 27, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 2,587 units |
| Distribution | Worldwide, USA and Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932740 | HOMEPUMP NSF Block Medical, Inc., Oct 6, 1993 |