FDAFDA · Food and drugs·Recall number Z-0879-2013
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.
Published March 6, 2013 · Recall initiated: October 4, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baylis Medical Company Inc.
- Distributor
- International distribution to the country of Australia.
- Lot
- Device Model #: 1 PMF 16-145-10CS. Lot number: PFFB 190811.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.