Baylis Medical Company Inc.: Medical Device Recall in 2013 - (Recall #: Z-0879-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 4, 2012

Date Posted: March 6, 2013

Recall Number: Z-0879-2013

Event ID: 64250

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

Status: Terminated

Product Quantity: 1780

Code Information:

Device Model #: 1 PMF 16-145-10CS. Lot number: PFFB 190811.

Distribution Pattern:

International distribution to the country of Australia.

Voluntary or Mandated:

Voluntary: Firm initiated