Z-0879-2013Class II

BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC...

Name: Z-0879-2013 BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC...
Creator: Baylis Medical Company Inc.
Published: 2012-10-04
License: https://open.fda.gov/license/

Baylis Medical Co., Inc. / initiated 2012-10-04 / Terminated / root cause: packaging

FDA source

Baylis Medical Company Inc. began a recall of 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... on 2012-10-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0879-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-04
Posted: 2013-02-26
Terminated: 2013-05-23
Recalling firm: Baylis Medical Co., Inc.
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.
Product code: GXI Probe, Radiofrequency Lesion
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
Root cause tag: packaging
FDA root cause: Packaging
Action: 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.
Quantity in commerce: 1780
Distribution: International distribution to the country of Australia.
Product codes and lots: Device Model #: 1 PMF 16-145-10CS. Lot number: PFFB 190811.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0879-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0879-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-26

Product code GXI

K972846Class IIBmc RF CannulaBaylis Medical Co., Inc. / cleared 1998-07-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)