Medical device recalls Moderate risk

Advanced Medical Solutions Ltd. recalls MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8…

Recall date
October 1, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0619-2025
FDA classification
Class II
Brand / firm
Advanced Medical Solutions Ltd.
Sold / distributed
U.S. Nationwide distribution in the states of IL, TX, and VA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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