Recall Z-2956-2011 · CAC Apparatus, Autotransfusion

Haemonetics Corporation

Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System Model 2050 US Models Out-Side the US: 02050-UK, 02050-ES, 02050-IT, 02050-NL, 02050-GE, 02050-FR, 02050-JA The Haemonetics Cardiovascular Perioperative Autotransfusion System for Use (cardioPAT) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgic

Date	Aug 5, 2011 (initiated Jul 27, 2011)
Status	Terminated
Reason	Updated Operations Manual for the deployment of the spill collection system and cleaning
Root cause	Component design/selection
Action	Haemonetics sent a "FIELD NOTIFICATION: UPDATE OF CardioPAT OPERATIONS MANUAL FOR DEPLOYMENT OF SPILL COLLECTION BAG AND CLEANING" letter dated July 27, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter requests that customers complete an enclosed Customer Confirmation sheet indicating that the affected devices are in their possession and to return the sheet via fax to Haemonetics at 781-987-9252. Additionally, instructions for deployment of the spill collection drainage system, revised Operations Manual and
Quantity	316 units
Distribution	Worldwide Distribution--USA (nationwide) and the countries of Canada, France, Germany, Great Britain, Italy, Japan, Spain, and The Netherlands.
FDA record	Open on fda.gov

510(k) clearances named in this recall

K053000

HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
Haemonetics Corp., Nov 21, 2005