Medical device recalls Moderate risk

Andover Healthcare Inc. recalls Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap

Recall date
June 19, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0182-2020
FDA classification
Class II
Brand / firm
Andover Healthcare Inc.
Sold / distributed
US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA

Why it was recalled

Incomplete packaging seal of sterile product

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap

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