Medical device recalls Moderate risk

Aesculap Implant Systems LLC recalls Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, prod…

Recall date
October 1, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1449-2022
FDA classification
Class II
Brand / firm
Aesculap Implant Systems LLC
Sold / distributed
United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI

Why it was recalled

Packaging seal integrity not validated resulting in a lack of sterility assurance.

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

What was recalled

Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.

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