Medical device recalls Moderate risk

Atrium Medical Corporation recalls Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010

Recall date
January 20, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1222-2017
FDA classification
Class II
Brand / firm
Atrium Medical Corporation
Sold / distributed
Nationwide

Why it was recalled

Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2)

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

What was recalled

Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010

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