Recall Z-0358-2007

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.

FDA-determined cause: Other

Action taken

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.