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Recall Observatory FDA recall evidence

Device 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.

Z-0619-2025

October 01, 2024

Class II

Product summary

Firm
Advanced Medical Solutions Ltd.
Event
Event 95613
Status
Ongoing
Classification
Class II
Quantity
1,800 boxes
Official record key
device-enforcement:Z-0619-2025

Official wording

Reason: Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.

Code information: Model Number: MSC7044EP UDI-DI code: 10080196296842 Lot Number: W00070789 Model Number: MSC7048EP UDI-DI code: 10080196296828 Lot Number: W00070988

Distribution pattern: U.S. Nationwide distribution in the states of IL, TX, and VA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    packaging pouch that compromise the device's ability to maintain a sterile