FDA-Device2017-02-22Class II

Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008

Atrium Medical Corporation
Hazard

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)

Sold states
Nationwide
Affected count
660 cases (10/case)
Manufactured in
5 Wentworth Dr, N/A, Hudson, NH, United States
Products
Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1221-2017

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