FDAClass IIDecember 11, 2024

Medline Maxorb Extra Alginate Wound Dressing 4x4 Square recall: Sterility Concern

MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wound…

Why was Medline Maxorb Extra Alginate Wound Dressing 4x4 Square recalled?

Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Model Number: MSC7044EP UDI-DI code: 10080196296842 Lot Number: W00070789 Model Number: MSC7048EP UDI-DI code: 10080196296828 Lot Number: W00070988

Product
MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wound…
Recalling firm
Advanced Medical Solutions Ltd.
Quantity
1,800 boxes
Distribution
U.S. Nationwide distribution in the states of IL, TX, and VA.
Recall date
December 11, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls