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About US FDA Alert Regarding
China Made Plastic Syringes Quality Failures
As per recent safety communication
issued by the U.S. Food and Drug Administration (FDA) for
consumers, health care providers, and health care facilities, FDA
is evaluating the potential for device failures (such as leaks,
breakage, and other problems) with plastic syringes manufactured
in China.
Generally, a syringe is used to
inject fluid into, or withdraw fluid from, the body and can be
used in a variety of clinical and home health settings. Some
syringes may also be used with infusion pumps to deliver fluids
into the body in a controlled manner.
This alert was for Syringes used for
injecting fluids into, or withdrawing fluids from, the body and
not glass syringes, pre-filled syringes, or syringes used for oral
or topical purposes.
FDA is aware of quality issues from
recent syringe recalls, Medical Device Reports (MDRs), and
additional complaints about syringes made at various manufacturing
sites in China.
Quality issues reported have
included leaks, breakage, and other problems after manufacturers
made changes to the syringe dimensions. These quality issues may
affect the performance and safety of the syringes.
The differing dimensions reportedly
affected their use with syringe pumps, potentially resulting in
pump performance issues like overdose, underdose, delay in
therapy, and delays in occlusion alarms.
In one of the recalls by a leading
US Company, it was found that the Single Use Sterile Syringes had
the potential to leak blood or heparin back or from the syringe.
There were also reports of an unknown black material inside the
syringe. Use of the syringes, according to FDA, could cause
serious adverse health consequences including sepsis and blood
loss due to leakage, or risks like incorrect heparin dosage.
The FDA is working with federal
partners to further test syringes manufactured in China and may
prevent syringes made in China from entering the United States.
(Ref : https://www.fda.gov/medical-devices/safetycommunications/evaluating-plastic-syringes-made-china-potential-devicefailures-fda-safety-communication)
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