Device product

Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008

Z-1221-2017

January 20, 2017

Class II

Product summary

Firm: Atrium Medical Corporation
Event: Event 76138
Status: Terminated
Classification: Class II
Quantity: 660 cases (10/case)
Official record key: device-enforcement:Z-1221-2017

Official wording

Reason: 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)

Code information: All Lot Numbers With Expiration Date Prior To December 2019

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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)