FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: Right Heart Catheter Product Line: Catalog Number 601261-----WP605P Wedge Press Cath.
- Recall number
- Z-0997-05
- Recalling firm
- B. Braun Medical, Inc.
- Product
- Right Heart Catheter Product Line: Catalog Number 601261-----WP605P Wedge Press Cath.
- 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
- 93 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: 601261. Lot Number, Exp Date: 0060461139, 5/31/05; 0060468252, 6/30/05; 0060484327, 7/31/05; 0060490856, 8/31/05; 0060534557, 12/31/05; 0060541502, 1/31/06; 0060558248, 2/28/06; 0060561935, 3/31/06; 0060565937, 4/30/06; 0060572444, 4/30/06; 0060577415, 5/31/06; 0060708815, 6/30/06; 0060710255, 7/31/06; 0060733103, 12/31/06; 0060743198, 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
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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