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 surgical procedures, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.
This recall has been terminated (originally issued August 5, 2011).
- Company
- Haemonetics Corporation
- Recall Initiated
- July 27, 2011
- Posted
- August 5, 2011
- Terminated
- June 9, 2014
- Recall Number
- Z-2956-2011
- Quantity
- 316 units
- Firm Location
- Braintree, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Updated Operations Manual for the deployment of the spill collection system and cleaning
Distribution
Worldwide Distribution--USA (nationwide) and the countries of Canada, France, Germany, Great Britain, Italy, Japan, Spain, and The Netherlands.
Lot / Code Info
All serial numbers
Root Cause
Component design/selection
Action Taken
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 Quick Reference Guide Addendum are enclosed with the letter. Contact Haemonetics at 1-800-537-2802 for questions regarding this notice..