FDAFDA · Food and drugs·Recall number Z-0618-2025
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.
Published December 11, 2024 · Recall initiated: October 1, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Advanced Medical Solutions Ltd.
- Distributor
- U.S. Nationwide distribution in the states of IL, TX, and VA.
- Lot
- Model Number: 3562 UDI-DI code: 10612479193861 Lot Number: W00070426
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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