Z-2346-2015Class II

Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236

Name: Z-2346-2015 Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
Creator: Atrium Medical Corporation
Published: 2015-06-19
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2015-06-19 / Terminated / root cause: manufacturing process

FDA source

Atrium Medical Corporation began a recall of Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236 on 2015-06-19. FDA classified it as Class II and gives the reason as "Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2346-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-19
Posted: 2015-08-05
Terminated: 2016-03-21
Recalling firm: Atrium Medical Corporation
Product: Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
Product code: GBZ Catheter, Cholangiography
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
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Atrium Medical notified accounts by letter dated 6/18/15, explaining the mislabeled inner units. If any product is discovered with incorrect labeling, the product may be used or product may be returned for credit. contact your local Atrium/Maquet chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST).
Quantity in commerce: 62 cases (10/cs)=620 units
Distribution: AZ, CA, LA. IN, NC, TN, TX, VA
Product codes and lots: Lot Number : ME215673 EXp: 2019/09

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2346-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2346-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-05

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)