FDAClass IIMay 10, 2017

Dressing Back recall: Sterility Concern

Dressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and…

Why was Dressing Back recalled?

They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.

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?

D163404

Product
Dressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and…
Recalling firm
Breg Inc
Quantity
2,609 units total
Distribution
US Nationwide Distribution
Recall date
May 10, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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