BMC RF Cannula Curved Sharp RadiOpaque recall
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…
Why was BMC RF Cannula Curved Sharp RadiOpaque 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Device Model #: 1 PMF 16-145-10CS. Lot number: PFFB 190811.
- 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…
- Recalling firm
- Baylis Medical Company Inc.
- Quantity
- 1780
- Distribution
- International distribution to the country of Australia.
- Recall date
- March 6, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)