Device 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.
Z-0619-2025
Product summary
- Event
- Event 95613
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,800 boxes
- Official record key
device-enforcement:Z-0619-2025
Official wording
Reason: Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Code information: Model Number: MSC7044EP UDI-DI code: 10080196296842 Lot Number: W00070789 Model Number: MSC7048EP UDI-DI code: 10080196296828 Lot Number: W00070988
Distribution pattern: U.S. Nationwide distribution in the states of IL, TX, and VA.
Derived failure modes
-
Sterility assurance
packaging pouch that compromise the device's ability to maintain a sterile