BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain.
FDA Recall Z-0879-2013 · Posted 2013-02-26
Advertisement
Recalling FirmBaylis Medical Company Inc.
Recall StatusTerminated
Product CodeGXI
Date Initiated2012-10-04
Date Terminated2013-05-23
Product Quantity1780
Reason for Recall
A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. Thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. The cannulas were not used on any patients, as the unsealed packages
Firm Action
A recall was initiated on 10/04/2012 and a letter was sent out to the distributor with a Fax-back Acknowledgment Form. The letter described the issue and provided recommendations and a contact number.
Root Cause
Packaging
Distribution Pattern
International distribution to the country of Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement