Z-0582-2017Class II

Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evacuation of air...

Name: Z-0582-2017 Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evacuation of air...
Creator: Atrium Medical Corporation
Published: 2016-10-26
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2016-10-26 / Terminated / root cause: labeling and UDI

FDA source

Atrium Medical Corporation began a recall of Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum on 2016-10-26. FDA classified it as Class II and gives the reason as "Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains". 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-0582-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-26
Posted: 2016-11-16
Terminated: 2018-10-09
Recalling firm: Atrium Medical Corporation
Product: Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Product code: GBZ Catheter, Cholangiography
Reason for recall: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Atrium Medical issued an "Urgent Medical Device Recall (Removal)" communication to customers on 10/26/16 via FedEx 2 day delivery. The recall identifies the problem, product, and risk factors. In addition, it provides instructions on how to handle product that may be affected. Accounts are to read the letter completely and share with all users and staff. They have been requested to complete the enclosed Recall Reply Form, acknowledging receipt of the notice; and, remove and quarantine any affected product for return. Additionally, obtain product from an alternate supplier because replacement product is not available as all Trocar catheters have been discontinued. Contact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm, for a Return Goods Authorization to return the product and receive credit.
Quantity in commerce: 7043 cases (10/cs)
Distribution: Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0582-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0576-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16
Z-0577-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16
Z-0578-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16
Z-0579-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16
Z-0580-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16
Z-0581-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16
Z-0582-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16
Z-0583-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16

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)