Medical device recalls Moderate risk

Advanced Medical Solutions Ltd. recalls McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute…

Recall date
October 1, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0618-2025
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

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

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