Z-0618-2025 Class II Ongoing
FDA device recall Z-0618-2025 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: 8000 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
- 8000 boxes
Product Description
McKesson Calcium Alginate Dressing MFR# 3562 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: 3562 UDI-DI code: 10612479193861 Lot Number: W00070426