FDAClass IIApril 13, 2016

MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French recall

MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula

Why was MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French recalled?

Complaints that the cannula bent/broke during surgery.

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?

0913228216, 0414243005, 0215266350, 0415269875, and 0515271334.

Product
MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
Recalling firm
MicroAire Surgical Instruments, LLC
Quantity
37
Distribution
Worldwide Distribution. US nationwide including Puerto Rico, Australia, Bangladesh, Czech Republic, India, Japan, Lebanon, New Zealand, Norway, Singapore, Switzerland, Taiwan, and Turkey.
Recall date
April 13, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls