ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01, I-Flow Corporation, Lake Fores
FDA device recall Z-0057-2008 · posted 2007-10-06 · Terminated
Recall details
- Recalling firm
- I-Flow Corporation
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MED
- Quantity affected
- 2,587 units
- Distribution
- Worldwide, USA and Australia
- Date initiated
- 2007-03-27
- Date posted
- 2007-10-06
- Date terminated
- 2009-10-07
- Location
- Lake Forest, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
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| HOMEPUMP NSF (K932740) | Block Medical, Inc. | 1993-10-06 |