Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion)
This recall has been terminated (originally issued December 8, 2007).
- Company
- Haemonetics Corporation
- Recall Initiated
- October 15, 2007
- Posted
- December 8, 2007
- Terminated
- March 19, 2012
- Recall Number
- Z-0358-2008
- Quantity
- 106 units
- Firm Location
- Braintree, MA
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide: USA including states of CA, CT, FL, IN, KY, MI, NC,NE, NH, PA, RI, SC,TX, and WA
Lot / Code Info
All Serial numbers
Root Cause
Labeling design
Action Taken
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.
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