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Terminated

Right Heart Catheter Product Line: Catalog Number 604103-------------T047(97) 427D4036I.

FDA Recall Z-1008-05 · Posted 2005-07-16

Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeDYG
Date Initiated2005-05-25
Date Terminated2006-12-14
Product Quantity231 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.

K841639NOVA BALLOON THERMODILUTION CATH.Nova Medical Specialties · 1984-08-12K832287NOVA BALLOON THERMODILUTION INFUSIONNova Medical Specialties · 1983-10-19K822806BALLOON WEDGE PRESSURE, ANGIOGRAPHICNova Medical Specialties · 1982-11-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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