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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls

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 Class 2 Recall
ON-Q PainBuster
see related information
Date Posted January 18, 2007
Recall Number Z-0358-2007
Product I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742
Code Information Lot numbers: 662449 & 662742
Recalling Firm/
Manufacturer
I-Flow Corporation
20202 Windrow Dr
Lake Forest, California 92630-8152
For Additional Information Contact Shane Noehre
949-206-2653
Reason for
Recall
The pump flow rate labeling may not match the package labeling. The label on filter may not match the label on the top of the pump or the package labeling.
Action A Recall Notification Letter was faxed to affected customers on November 29, 2006. Affected customers were notified of the identity of product subject to recall, the reason for recall, and instructed to quarantine immediately any remaining inventory. A Customer Response (FAX back) form was included with the Recall Notification Letter (dated November 29, 2006). Affected customers were requested to return the FAX back form to I-Flow within 48 hours of receipt. The fax back form indicates the quantity of remaining product from each lot the customer may have.
Quantity in Commerce 3475
Distribution Nationwide
 
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