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FDAFDA · Food and drugs·Recall number Z-0619-2025

MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.

Published December 11, 2024 · Recall initiated: October 1, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Advanced Medical Solutions Ltd.
Distributor
U.S. Nationwide distribution in the states of IL, TX, and VA.
Lot
Model Number: MSC7044EP UDI-DI code: 10080196296842 Lot Number: W00070789 Model Number: MSC7048EP UDI-DI code: 10080196296828 Lot Number: W00070988
Risk classification
Class II
Area (FDA)
device
Country
United Kingdom

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