Z-0619-2025 Class II Ongoing
FDA device recall Z-0619-2025 was initiated by Advanced Medical Solutions Ltd. on October 1, 2024 and is designated Class II. Reason for recall: Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier. The recall status is ongoing. Affected quantity: 1,800 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2024
- Initiation Date
- October 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,800 boxes
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.
Distribution Pattern
U.S. Nationwide distribution in the states of IL, TX, and VA.
Code Information
Model Number: MSC7044EP UDI-DI code: 10080196296842 Lot Number: W00070789 Model Number: MSC7048EP UDI-DI code: 10080196296828 Lot Number: W00070988