Recall Z-0879-2013— Baylis Medical Company Inc.

Name: FDA recall Z-0879-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-04

Class II · Terminated

Class II FDA medical device recall by Baylis Medical Company Inc., initiated 2012-10-04, terminated 2013-05-23. It names one FDA 510(k) clearance: K972846. Product: 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.. Reason: 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.

Recalling firm: Baylis Medical Company Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-10-04
Terminated: 2013-05-23
Firm location: Mississauga, Ontario, Canada

510(k) clearances named in this recall

1 on FDA's record

K972846 — BMC RF CANNULABaylis Medical Co., Inc.·cleared 1998-07-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.