Recall Z-1221-2017— Atrium Medical Corporation

Name: FDA recall Z-1221-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-20

Class II · Terminated

Class II FDA medical device recall by Atrium Medical Corporation, initiated 2017-01-20, terminated 2020-11-03. It names one FDA 510(k) clearance: K831931. Product: Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008. 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).

Recalling firm: Atrium Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-01-20
Terminated: 2020-11-03
Firm location: Hudson, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K831931 — ATRIUM THORACIC CATHETERAtrium Medical Corp.·cleared 1983-10-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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)

Data sourced from openFDA. This site is unofficial and independent of the FDA.