FDAClass IIDecember 11, 2024

McKesson Calcium Alginate Dressing MFR# 3562 Wound recall: Sterility Concern

McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor…

Why was McKesson Calcium Alginate Dressing MFR# 3562 Wound 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: 3562 UDI-DI code: 10612479193861 Lot Number: W00070426

Product
McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor…
Recalling firm
Advanced Medical Solutions Ltd.
Quantity
8000 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