Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010

FDA Recall Z-1222-2017 · Posted None

Recalling FirmAtrium Medical Corporation
Recall StatusTerminated
Product CodeGBZ
Date Initiated2017-01-20
Date Terminated2020-11-03
Product Quantity1394 cases (10/case)

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)

Firm Action

Marquet/Atrium notified consignees by letter dated 01/20/17 informing of the Labeling Icon Clarification. The thoracic catheter labeling is being updated for future production. Users should be made aware of this Field Notification and may continue to use the affected thoracic catheter products with the current labeling. Questions, please contact your local Maquet/Atrium thoracic catheter representative or Maquet Customer Service at 1-800-528-7486 or 603-880-1433, Monday through Friday between 8:00 am and 5:00 pm (EST).

Root Cause

Labeling design

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K831931ATRIUM THORACIC CATHETERAtrium Medical Corp. · 1983-10-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑