Baylis Medical Recalls Unsealed Sterile RF Cannulas for Pain Relief
Baylis Medical is recalling 1,780 sterile RF cannulas distributed to Australia because some pouches were not sealed, risking sterility loss.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a packaging defect that compromises sterility, but the source explicitly states the devices were not used on patients, and no injuries or illnesses are reported.
Plain-English summary
Baylis Medical Company Inc. is recalling 1,780 units of the BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The devices are intended for use in radiofrequency heat lesion procedures for the relief of pain. The recall affects devices with Model Number 1 PMF 16-145-10CS and Lot Number PFFB 190811. The affected products were distributed internationally to Australia.
The recall was initiated after a report indicated that upon opening a box containing 10 sterile cannulas, a nurse found that the pouch packages for 5 of the 10 individually packaged cannulas had not been sealed along one edge. This defect allowed the pouch to remain open, creating a risk that the device could fall out of the pouch and onto the floor when retrieved from the shelf box. The source text notes that the cannulas were not used on any patients because the unsealed packages were identified prior to use.
Healthcare providers and facilities in Australia should check their inventory for the specific model and lot numbers listed above. If the affected devices are found, they should be removed from service and returned to Baylis Medical Company Inc. according to the recall instructions.
The recalled product
- 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 num
- Manufacturer
- Baylis Medical Company Inc.
- Affected units
- 1,780
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Device Model #: 1 PMF 16-145-10CS. Lot number: PFFB 190811.
Distribution
Distribution scope not specified by the agency.
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