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Recall Observatory FDA recall evidence

Device 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.

Z-0618-2025

October 01, 2024

Class II

Product summary

Firm
Advanced Medical Solutions Ltd.
Event
Event 95613
Status
Ongoing
Classification
Class II
Quantity
8000 boxes
Official record key
device-enforcement:Z-0618-2025

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: 3562 UDI-DI code: 10612479193861 Lot Number: W00070426

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