Device product
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.
Z-0618-2025
Product summary
- Event
- Event 95613
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8000 boxes
- Official record key
device-enforcement:Z-0618-2025
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: 3562 UDI-DI code: 10612479193861 Lot Number: W00070426
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