Recall Z-0619-2025— Advanced Medical Solutions Ltd.
Class II · Ongoing
Class II FDA medical device recall by Advanced Medical Solutions Ltd., initiated 2024-10-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier..
- Recalling firm
- Advanced Medical Solutions Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-01
- Firm location
- Winsford, United Kingdom
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.
Reason for recall
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Data sourced from openFDA. This site is unofficial and independent of the FDA.