PlainRecalls
FDA Devices Moderate Class II Terminated

Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008

Reported: February 22, 2017 Initiated: January 20, 2017 #Z-1221-2017

Product Description

Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008

Reason for Recall

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)

Details

Units Affected
660 cases (10/case)
Distribution
Nationwide
Location
Hudson, NH

Frequently Asked Questions

What product was recalled?
Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008. Recalled by Atrium Medical Corporation. Units affected: 660 cases (10/case).
Why was this product 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)
Which agency issued this recall?
This recall was issued by the FDA Devices on February 22, 2017. Severity: Moderate. Recall number: Z-1221-2017.