China has returned 272 heart pacemakers imported from the United
States after they failed quality control inspections, China's top
quality control agency announced on Monday.
The General Administration of Quality Supervision, Inspection
and Quarantine (AQSIQ) said that the heart pacemakers, valued at
about US$240,000 in total, were detained by the Shanghai Entry-Exit
inspection and Quarantine Bureau at the end of April.
The administration said the pulse strength of the devices, made
by St. Jude Medical Inc., was not in line with its indicated
properties.
The difference between the testing parameters and the default
ones exceeded the two-percent limit set by the Chinese technical
authorities, the AQSIQ said.
The pacemakers pose potential threats to patients' lives as they
could cause misdiagnoses, the statement said, citing unnamed
doctors.
In 2001, China's State Food and Drug Administration (SFDA)
launched an urgent investigation into four types of pacemakers
produced by St. Jude Medical Inc. due to reliability issues. The
investigation has resulted in banning pacemaker imports.
The quality control agency reported that they would ask the US
producers to resolve the problems and improve the product quality.
Imports will be resumed once the problems are resolved, said the
AQSIQ.
An official from the AQSIQ said that, generally speaking, a ban
can be rescinded within six months to one year.
China and the United States have seized a number of products
deemed unsafe from each other this year.
The US blamed melamine-tainted wheat proteins from China for the
deaths of cats and dogs in North America. The US also claimed that
some Chinese toothpastes, tires and seafood were unsafe.
Meanwhile, China has seized orange pulp and dried apricots from
the United States, claiming that it contained excessive bacteria,
mildew and sulfur dioxide.
The international community commonly requires to raise product
quality and ensure food safety, said Wei Chuanzhong, deputy chief
of the AQSIQ.
The two countries have agreed on an initial draft of a
memorandum on food safety cooperation. They will hold a second
summit on product safety this September in Maryland.
(Xinhua News Agency August 21, 2007)