FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per carton.-B. Braun Medical, Allentown, Pa.
- Recall number
- Z-1116-2007
- 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.
- Status
- Terminated
- Initiated
- 2007-06-05
- Posted
- 2007-07-23
- Terminated
- 2007-10-31
- Reason
- Cracks at the Catheter Tip
- 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
- 4,695
- Distribution
- International ONLY- Japan
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K832287"]
- PMA numbers
- not on file
- Product code
- DYG
- Firm FEI
- 2523676
- Firm city
- Allentown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28