BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic… recallZ-0879-2013 · Baylis Medical Company Inc. · initiated Oct 4, 2012
Class II Terminated All recalls posted in February 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baylis Medical Company Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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
FDA root cause category: Packaging
What the company is doing
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.
Recall details
- Recall number
- Z-0879-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 4, 2012
- Posted by the FDA
- Feb 26, 2013
- Recalling firm
- Baylis Medical Company Inc.
- Quantity
- 1780
- Product code
- GXI
- FDA submissions
- K972846
- Distribution
- International distribution to the country of Australia.
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.
Code information (models, lots, serial numbers)
Device Model #: 1 PMF 16-145-10CS. Lot number: PFFB 190811.
Other devices under the same FDA submission
4 devices cleared under K972846 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- RadiOpaque Radiofrequency Cannula PMF21-100-5Avanos Medical, Inc. · Probe, radiofrequency lesion3 reports
- RadiOpaque Radiofrequency Cannula PMF20-100-10CSAvanos Medical, Inc. · Probe, radiofrequency lesion2 reports
- RadiOpaque Radiofrequency Cannula PMF22-100-10CSAvanos Medical, Inc. · Probe, radiofrequency lesion2 reports
- Radiofrequency Cannulae PMF22-100-5Avanos Medical, Inc. · Probe, radiofrequency lesion1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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