FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: Right Heart Catheter Product Line: Catalog Number 604028------------T047(90) 427D1022I.
- Recall number
- Z-1004-05
- Recalling firm
- B. Braun Medical, Inc.
- Product
- Right Heart Catheter Product Line: Catalog Number 604028------------T047(90) 427D1022I.
- Status
- Terminated
- Initiated
- 2005-05-25
- Posted
- 2005-07-16
- Terminated
- 2006-12-14
- Reason
- Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Root cause
- Other
- Action
- The firm sent out recall notification letters to the Directors of Materials Management on 5/27/2005.
- Quantity
- 398 units
- Distribution
- Product was distributed to distributors and hospitals nationwide. Also, the products were distributed to Germany and Japan.
- Lot, serial or model codes
- Catalog Number 604028. Lot Number, Exp.Date: 0060714530, 8/31/06; 0060714554, 10/31/06; 0060715260, 9/30/06; 0060716585, 8/31/06; 0060721764, 10/31/06; 0060730636, 11/30/06; 0060737274, 12/31/06; 0060738518, 11/30/06.
- 510(k) numbers
- ["K822806","K832287","K841639"]
- 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