Medical device recalls Moderate risk

Andover Healthcare Inc. recalls Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)

Recall date
April 2, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1828-2024
FDA classification
Class II
Brand / firm
Andover Healthcare Inc.
Sold / distributed
US Nationwide distribution in the states of CA, CO, GA, IA, IN, OH, MN, NC, PA, TX, VA, WA.

Why it was recalled

A packaging seal gap could impact the sterility of the 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 CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)

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