FDA-Device2024-12-11Class II
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.
Advanced Medical Solutions Ltd.
Hazard
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Sold states
U.S. Nationwide distribution in the states of IL, TX, and VA.
Affected count
1,800 boxes
Manufactured in
Unit A, 33 Road One, Winsford, United Kingdom
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0619-2025Don't want to check this manually?
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