Medline MaxOrb Extra Alginate Wound Dressing Recalled for Packaging Defect
Advanced Medical Solutions is recalling 1,800 boxes of Medline MaxOrb Extra Alginate Wound Dressing due to defects in the primary packaging pouch that compromise sterile barrier integrity. Products affected were distributed in 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 FDA Class II recall involves a defect that compromises the sterile barrier of a medical device used on wounds. While no injuries have been reported, the loss of sterile barrier integrity on a wound dressing poses a direct risk of contamination, meeting the criteria for high-severity rating.
Plain-English summary
Advanced Medical Solutions is recalling 1,800 boxes of Medline MaxOrb Extra Alginate Wound Dressing due to defects in the primary packaging pouch. The defects compromise the device's ability to maintain a sterile barrier, which is essential for wound protection.
The recalled products include the 4X4 Square model (Reference MSC7044EP, Lot Number W00070789) and the 4X8 Rectangle model (Reference MSC7048EP, Lot Number W00070988). These products were distributed nationwide in Illinois, Texas, and Virginia.
Alginate wound dressings are indicated for moderate to heavily exuding chronic and acute wounds and to control minor bleeding in superficial wounds. A compromised sterile barrier increases the risk of contamination.
Consumers who have these products should stop using them and contact their healthcare provider for guidance. No illnesses or injuries have been reported.
The recalled product
- Product
- MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP 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-compromise
- contamination-risk
Distribution
Distributed nationwide across the United States.
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