Right Heart Catheter Product Line: Catalog Number 604028------------T047(90) 427D1022I.
FDA Recall Z-1004-05 · Posted 2005-07-16
Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeDYG
Date Initiated2005-05-25
Date Terminated2006-12-14
Product Quantity398 units
Reason for Recall
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
Firm Action
The firm sent out recall notification letters to the Directors of Materials Management on 5/27/2005.
Root Cause
Other
Distribution Pattern
Product was distributed to distributors and hospitals nationwide. Also, the products were distributed to Germany and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.