ClearanceBrief
Recall Z-2420-2011 ยท CAC Apparatus, Autotransfusion

Haemonetics Corporation

Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion System US Only: 1050-110-ENG Outside US: 1050-110-ENG, I050-240-XXX (generic), 1050-240-ENG, 1050-240-SPN, 1050-240-ITL, 1050-240GER, 1050-240-DUT, 1050-240-FRN, 1050-240-CZE, 1050-IIO-JPN. Provides perioperative autotransfusion ( salvaging and reinfusing red blood cells (RBC's) from blood shed from patients undergoing orthopedic surg

DateJun 7, 2011 (initiated Apr 29, 2011)
StatusTerminated
Reason2 Models Model 1: OrthoPAT devices with no centrifuge drain spill containment system may have potential for fluid contamination leading to potential spark or smoke may occur are recalled Model 2: OrthoPat equipped with a spill collection drainage system updated with revised Instructions for Use and Quick reference Guide Addendum
Root causeDevice Design
ActionThe firm, Haemonetics, sent an "Urgent Field Recall" letter dated April 29, 2011 to all customers. The letter describes the product, problem and actions to be taken. This recall covers the 2 models. Model 1: OrthoPAT devices without drain ports (Serial numbers 00001 through 02279-T). All OrthoPAT devices without drain ports worldwide, will be removed from distribution and scrapped. Model 2: OrthoPAT devices with drain ports (serial numbers beginning with 02280-T and higher). All OrthoPAT devices with drain ports will remain in clinical use and will receive updated labeling. The customers
Quantity2976 units
DistributionWorldwide distribution: USA (nationwide) and countries including: Austria, Australia, Belgium, Switzerland, Canada, China, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Guatemala, Ireland, Israel, India, Italy, Japan, Lithuania, Luxembourg, Latvia, Monaco, Netherlands, Norw
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K992723ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
Transfusion Technologies Corp., Oct 18, 1999