Z-0484-2024Class II

Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036

Name: Z-0484-2024 Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036
Creator: Atrium Medical Corporation
Published: 2023-09-29
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2023-09-29 / Open, Classified / root cause: manufacturing process

FDA source

Atrium Medical Corporation began a recall of Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036 on 2023-09-29. FDA classified it as Class II and gives the reason as "A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0484-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-29
Posted: 2023-12-02
Recalling firm: Atrium Medical Corporation
Product: Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Product code: GBZ Catheter, Cholangiography
Reason for recall: A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An Urgent Medical Device - Removal notice was sent via Fed-Ex on October 25, 2023. The letter advises customers to check for and remove from inventory Atrium Firm PVC Catheter 36 FR Straight, part number 15036, lot ME234686. Forward this information to all current and potential Atrium Firm PVC Thoracic Catheter 36FR Straight users within your hospital / facility, or to any customer product was further distributed to. Contact your local Atrium/Getinge Customer Service department at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone)to request a return authorization (RMA) and shipping instructions to return any affected product.
Quantity in commerce: 2460 units (246 cases, 10 units/case)
Distribution: US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TX
Product codes and lots: UDI-DI: 00650862150360, lot ME234686, expiration date 2023-02-24.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0484-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0484-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01

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)