Class II — Advanced Medical Solutions Ltd.
| Recalling firm | ADVANCED MEDICAL SOLUTIONS GROUP PLC |
|---|---|
| Registered facility | View this company's 7 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier. |
| 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. |
| Quantity | 1,800 boxes |
| Distribution | U.S. Nationwide distribution in the states of IL, TX, and VA. |
| Initiated | 2024-10-01 |
| Classified | 2024-12-04 |
| Recall number | Z-0619-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Advanced Medical Solutions Ltd. (Z-0619-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95613/
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