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U.S. Department of Health and Human Services

Class 2 Device Recall BMC RF Cannula

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 Class 2 Recall
BMC RF Cannula
see related information
Date Posted February 26, 2013
Recall Status1 Terminated on May 23, 2013
Recall Number Z-0879-2013
Recall Event ID 64250
Premarket Notification
510(K) Number
K972846 
Product Classification Probe, Radiofrequency Lesion - Product Code GXI
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.
Code Information Device Model #: 1 PMF 16-145-10CS. Lot number: PFFB 190811.
Recalling Firm/
Manufacturer
Baylis Medical Company Inc.
5160 Explorer Drive #33
Mississauga, Ontario
For Additional Information Contact Meghal Khakhar
905-602-4875 Ext. 252
Manufacturer 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
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GXI and Original Applicant = BAYLIS MEDICAL CO., INC.
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