FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: Right Heart Catheter Product Line: Catalog Number 601129-----5011094 0106 x 1007BBMWS.
- Recall number
- Z-0995-05
- Recalling firm
- B. Braun Medical, Inc.
- Product
- Right Heart Catheter Product Line: Catalog Number 601129-----5011094 0106 x 1007BBMWS.
- 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
- 1077 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: 601129. Lot Number, exp.date: 0060436563, 3/31/05; 0060449283, 4/30/05; 0060460576, 6/30/05; 0060478672, 7/31/05; 0060479191, 6/30/05; 0060485755, 7/31/05; 0060488734, 8/31/05; 0060496446, 9/30/05; 0060514308, 10/31/05; 0060520693, 11/30/05; 0060541501, 1/31/06; 0060551085, 2/28/06; 0060558243, 3/31/06; 0060572138, 4/30/06; 0060572440, 4/30/06; 0060577179, 5/31/06; 0060577413, 4/30/06; 0060706970, 6/30/06; 0060710249, 8/31/06; 0060721648, 9/30/06; 0060724465, 10/31/06; 0060732313, 10/31/06; 0060738463, 12/31/06; 0060746723, 1/31/06.
- 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