Z-1012-05

Right Heart Catheter Product Line: Catalog Number 604315-------------406-1H-018 426D1009I18PP

Name: Z-1012-05 Right Heart Catheter Product Line: Catalog Number 604315-------------406-1H-018 426D1009I18PP
Creator: B. Braun Medical, Inc.
Published: 2005-05-25
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2005-05-25 / Terminated

FDA source

B. Braun Medical, Inc. began a recall of Right Heart Catheter Product Line: Catalog Number 604315-------------406-1H-018 426D1009I18PP on 2005-05-25. The reason FDA records is "Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1012-05
Status: Terminated
Initiated: 2005-05-25
Posted: 2005-07-16
Terminated: 2006-12-14
Recalling firm: B Braun Medical Inc
Product: Right Heart Catheter Product Line: Catalog Number 604315-------------406-1H-018 426D1009I18PP.
Product code: DYG Catheter, Flow Directed
Reason for recall: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
FDA root cause: Other
Action: The firm sent out recall notification letters to the Directors of Materials Management on 5/27/2005.
Quantity in commerce: 11 units
Distribution: Product was distributed to distributors and hospitals nationwide. Also, the products were distributed to Germany and Japan.
Product codes and lots: Catalog Number 604315. Lot Number, exp date: 0060514256, 01/31/06; 0060721684, 8/31/06.

Product code DYG

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)