BMC RF Cannula Curved Sharp RadiOpaque — Class II medical device recall Z-0879-2013
Terminated recall by Baylis Medical Company Inc., reported 2013-03-06. A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse,
| Recall number | Z-0879-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baylis Medical Company Inc., Mississauga, Ontario, Canada |
| Recall initiated | 2012-10-04 |
| Classified | 2013-02-26 |
| Reported by FDA | 2013-03-06 |
| Terminated | 2013-05-23 |
| Countries outside the US | AU |
| Quantity | 1,780 |
| Reason classes | sterility |
| Model numbers | 16-145-10CS |
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 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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0879-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.