FDA recall Z-0619-2025

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.

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-0619-2025