FDA Medical devices recall ·
MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE recall
- Recall number
- Z-0619-2025
- Date
- (initiated October 1, 2024)
- Company / brand
- Advanced Medical Solutions Ltd.
Unit A, Winsford, United Kingdom - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,800 boxes
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: MSC7044EP UDI-DI code: 10080196296842 Lot Number: W00070789 Model Number: MSC7048EP UDI-DI code: 10080196296828 Lot Number: W00070988
Distribution
U.S. Nationwide distribution in the states of IL, TX, and VA.
States: Illinois Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0619-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.