FDA recall Z-0618-2025

Advanced Medical Solutions Ltd. · Class II · 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.

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2024-10-01
Report date
2024-12-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Winsford, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0618-2025