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Terminated

Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per carton.-B. Braun Medical, Allentown, Pa.

FDA Recall Z-1116-2007 · Posted 2007-07-23

Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeDYG
Date Initiated2007-06-05
Date Terminated2007-10-31
Product Quantity4,695

Reason for Recall

Cracks at the Catheter Tip

Firm Action

On 6/5/07, a Product Removal Notice was issued to the only distributor that received the product in Japan

Root Cause

Other

Distribution Pattern

International ONLY- Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K832287NOVA BALLOON THERMODILUTION INFUSIONNova Medical Specialties · 1983-10-19

Official Source

View FDA Recall →

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

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