FDAClass IDecember 10, 2014

Mayo Stand Cover W/CSR Wrap recall: Sterility Concern

Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771. Used by medical staff to perform patient care procedures such as wound healing, suture removals…

Why was Mayo Stand Cover W/CSR Wrap recalled?

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

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 numbers: 111103390 112041455 112062288 112093634 113046894 113088762 140111121 140111176 140814743

Product
Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771. Used by medical staff to perform patient care procedures such as wound healing, suture removals…
Recalling firm
Customed, Inc
Quantity
10090
Distribution
US Distribution to Florida, New York and Puerto Rico..
Recall date
December 10, 2014
Classification
Class I
Status
Terminated
Agency
FDA (device)
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