FDAClass IIJune 24, 2015

Milex Omniflex Diaphragm recall

MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80

Why was Milex Omniflex Diaphragm recalled?

A diaphragm size 80 labeled box was incorrectly packaged with a size 85.

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?

Lot 153309

Product
MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
Recalling firm
CooperSurgical, Inc.
Quantity
200 units
Distribution
AK, CA, DC, FL, IL, ME, MT, NE, NJ, NM, NY, OK, OR, P A, VA, W A, and WI Foreign: CANADA, ENGLAND, and POLAND
Recall date
June 24, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls