Device Recall ONQ PainBuster 의 리콜

Recall

36984

Class 2

Z-0358-2007

2006-11-29

2007-01-18

Terminated

United States

2009-12-11

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49710

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.

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.