Haemonetics Cell Saver 5 Autogolous Blood Recovery System Model Numbr: LN02005-110-E
FDA Recall Z-0822-06 · Posted 2006-04-29
Recalling FirmHaemonetics Corporation
Recall StatusTerminated
Product CodeCAC
Date Initiated2005-12-21
Date Terminated2008-03-12
Product Quantity3 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.