Z-1221-2017Class II

Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008

Name: Z-1221-2017 Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
Creator: Atrium Medical Corporation
Published: 2017-01-20
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2017-01-20 / Terminated / root cause: labeling and UDI

FDA source

Atrium Medical Corporation began a recall of Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008 on 2017-01-20. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1221-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-20
Posted: 2017-02-16
Terminated: 2020-11-03
Recalling firm: Atrium Medical Corporation
Product: Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
Product code: GBZ Catheter, Cholangiography
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)
Root cause tag: labeling and UDI
FDA root cause: Labeling design
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).
Quantity in commerce: 660 cases (10/case)
Distribution: Nationwide
Product codes and lots: All Lot Numbers With Expiration Date Prior To December 2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1221-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1221-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-16
Z-1222-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-16

Product code GBZ

K831931Class IAtrium Thoracic CatheterAtrium Medical Corp. / cleared 1983-10-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)