Recall Z-2346-2015— Atrium Medical Corporation

Name: FDA recall Z-2346-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-19

Class II · Terminated

Class II FDA medical device recall by Atrium Medical Corporation, initiated 2015-06-19, terminated 2016-03-21. It names one FDA 510(k) clearance: K831931. Product: Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236. Reason: Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter.

Recalling firm: Atrium Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-06-19
Terminated: 2016-03-21
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 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236

Reason for recall

Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter

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