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Terminated

Haemonetics Cell Saver 5 Fast Pack List Number: 260

FDA Recall Z-0498-03 · Posted 2003-01-30

Recalling FirmHaemonetics Corporation
Recall StatusTerminated
Product CodeCAC
Date Initiated2002-12-17
Date Terminated2016-01-28
Product Quantity15,150

Reason for Recall

Disposable Set for Autologous Blood recovery may leak saline at the Y-connector

Firm Action

Haemonetics notified accounts of the recall on December 17, 2002 by fax. A hard copy of the same letter was sent to each customer via certified mail, return receipt on December 18 and 19. Users are requested to cease use of product and return product to Haemonetics.

Root Cause

Other

Distribution Pattern

Nationwide Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932890CELL SAVER 5 SYSTEMHaemonetics Corp. · 1994-01-05

Official Source

View FDA Recall →

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

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