CHICAGO (Reuters) - A U.S.-based unit of Terumo Corp said it has entered into a consent decree with the U.S. Food and Drug Administration and agreed to stop selling two of its products used in cardiopulmonary bypass surgery.
The consent decree stems from concerns raised by the FDA about quality system procedures at Terumo Cardiovascular Systems’ manufacturing plant in Ann Arbor, Michigan.
The products that can no longer be sold are the CDI 101 Hematocrit Oxygen Saturation Monitoring System and the Tenderflow Pediatric Arterial Cannulae. Cannulae are devices inserted into the heart to facilitate blood flow during surgery.
Terumo, the world’s largest maker of cardiopulmonary bypass products, can continue to sell other heart-lung machines, monitoring system hardware and cannulae made at the plant if customers sign a certificate of medical necessity, said company spokeswoman Barbara Schmid.
No injuries to patients were reported, and products made at Terumo plants in Maryland and Massachusetts are not affected, Schmid said. Terumo is not required to remove, recall or repair any products installed at customer facilities.
“We obviously take the FDA’s concerns very seriously, and we are committed to improving our quality systems to bring them into full compliance,” Schmid said.
Terumo also agreed to pay a fine of $35 million to the FDA should it fail to comply with the decree.
The agreement is subject to the approval of the U.S. District Court for the Eastern District of Michigan.
Reporting by Susan Kelly, editing by Gerald E. McCormick