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Terminated

Haemonetics Cell Saver 5+ Autogolous Blood Recovery System Model Number: LN02005-110EP

FDA Recall Z-0823-06 · Posted 2006-04-29

Recalling FirmHaemonetics Corporation
Recall StatusTerminated
Product CodeCAC
Date Initiated2005-12-21
Date Terminated2008-03-12
Product Quantity151 units

Reason for Recall

Device emits radiofrequency which exceed the IEC 60601-1-2 International Standard

Firm Action

Haemonetics notified accounts by Certified Letter on 12/21/05. A field correction will be schedule to replace the LCD .

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K014083HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEMHaemonetics Corp. · 2002-01-08

Official Source

View FDA Recall →

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

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