FDA Device recall Z-0618-2025
McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to cont…
- FDA Device
- Class II
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to cont… by Advanced Medical Solutions, citing due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0618-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-01 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Advanced Medical Solutions |
| Distribution | US |
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.
Reason
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Identifiers
| code_info | Model Number: 3562 UDI-DI code: 10612479193861 Lot Number: W00070426 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0618-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.