Reported Mar 6, 2013 · Terminated
BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula…
Baylis Medical Company Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baylis Medical Company Inc. · 5160 Explorer Drive #33 · Mississauga, Ontario · N/A
Is this the product you have?
- BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic
- Active Tip
10mmGauge 16 Ga
- Length100mm. 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
- Lot codes and dates
- Device Model #: 1 PMF 16-145-10CS
- Lot numberPFFB 190811
- Amount recalled
- 1780
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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