McKesson Calcium Alginate Wound Dressing Recalled for Sterile Barrier Defect
McKesson Calcium Alginate Dressing Model 3562 is recalled because defects in the primary packaging pouch compromise the sterile barrier. Lot number W00070426 affects approximately 8,000 boxes distributed across Illinois, Texas, and Virginia.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall with no reported illnesses or injuries. The defect—compromised sterile barrier integrity on a wound dressing—represents a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for Score 3 (High).
Plain-English summary
McKesson Calcium Alginate Dressing Model 3562 is a wound dressing device indicated for use on moderate to heavily exuding chronic and acute wounds and to control minor bleeding in superficial wounds.
Defects have been identified in the primary packaging pouch that compromise the device's ability to maintain a sterile barrier. Lot number W00070426 (UDI-DI code: 10612479193861) is affected. Approximately 8,000 boxes have been distributed across Illinois, Texas, and Virginia.
Advanced Medical Solutions Ltd., the manufacturer, initiated this recall due to the packaging defects that affect sterile barrier integrity.
The recalled product
- 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.
- Manufacturer
- Advanced Medical Solutions Ltd.
- Category
- Medical Device — Wound dressing
- Hazard
- sterile-barrier-defect
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: 3562 UDI-DI code: 10612479193861 Lot Number: W00070426
Distribution
Distributed nationwide across the United States.
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