Z-1116-2007

Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per...

Name: Z-1116-2007 Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per...
Creator: B. Braun Medical, Inc.
Published: 2007-06-05
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2007-06-05 / Terminated

FDA source

B. Braun Medical, Inc. began a recall of Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per carton.-B. Braun Medical, Allentown, Pa on 2007-06-05. The reason FDA records is "Cracks at the Catheter Tip". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1116-2007
Status: Terminated
Initiated: 2007-06-05
Posted: 2007-07-23
Terminated: 2007-10-31
Recalling firm: B Braun Medical Inc
Product: Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per carton.-B. Braun Medical, Allentown, Pa.
Product code: DYG Catheter, Flow Directed
Reason for recall: Cracks at the Catheter Tip
FDA root cause: Other
Action: On 6/5/07, a Product Removal Notice was issued to the only distributor that received the product in Japan
Quantity in commerce: 4,695
Distribution: International ONLY- Japan
Product codes and lots: Catalog numbers 604028: Lot numbers 60759210 exp 6/07, 60774338 exp 9/07, 60774339 exp 6/07, 60789198 exp 7/07, 60793228 exp 8/07, 60798079 exp 6/07, 60798080 exp 7/07, 60798858 exp 8/07, 60805581 exp 8/07, 60814631 exp 10/07, 60814632 exp 9/07, 60816722 exp 10/07, 60873702 exp 7/08, 60885381 exp 10/08, 60887358 exp 9/08, 60894377 exp 11/08, 60899729 exp 11/08, 60906657 exp 12/08, 60911647 exp 1/09, and 60916540 exp 3/09. --Catalog numbers 60416540: Lot numbers 60781356 exp 7/07 and 60798862

Product code DYG

K832287Class IINova Balloon Thermodilution InfusionNova Medical Specialties / cleared 1983-10-19

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)