Dressing M/U XL recall: Sterility Concern
Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad…
Why was Dressing M/U XL 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?
D163474, D163544
- Product
- Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad…
- 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)