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Terminated

Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion)

FDA Recall Z-0358-2008 · Posted 2007-12-08

Recalling FirmHaemonetics Corporation
Recall StatusTerminated
Product CodeCAC
Date Initiated2007-10-15
Date Terminated2012-03-19
Product Quantity106 units

Reason for Recall

Labeling (additional) use instructions: to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient's chest

Firm Action

Haemonetics issued a Labeling suppplement to users via a Field Notification letter on October 15, 2007. Users are provide additional Directions for use for the Operator's Guide and Quick Reference Guide.

Root Cause

Labeling design

Distribution Pattern

Nationwide: USA including states of CA, CT, FL, IN, KY, MI, NC,NE, NH, PA, RI, SC,TX, and WA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053000HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)Haemonetics Corp. · 2005-11-21

Official Source

View FDA Recall →

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

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