Recall Z-0358-2008 ยท CAC Apparatus, Autotransfusion
Haemonetics Corporation
Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion)
| Date | Dec 8, 2007 (initiated Oct 15, 2007) |
| Status | Terminated |
| Reason | Labeling (additional) use instructions: to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient's chest |
| Root cause | Labeling design |
| 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. |
| Quantity | 106 units |
| Distribution | Nationwide: USA including states of CA, CT, FL, IN, KY, MI, NC,NE, NH, PA, RI, SC,TX, and WA |
| 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 |