Advanced Medical Solutions Ltd.: Device Recall

Recall #Z-0619-2025 · 10/01/2024

Class II: Risk

Recall Details

Recall Number
Z-0619-2025
Classification
Class II
Product Type
Device
Recalling Firm
Advanced Medical Solutions Ltd.
Status
Ongoing
Date Initiated
10/01/2024
Location
Winsford, United Kingdom
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,800 boxes

Reason for Recall

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

Product Description

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.

Distribution Pattern

U.S. Nationwide distribution in the states of IL, TX, and VA.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.