Bayer—MEDRAD Stellant FLEX CT Syringes: May Develop Holes and/or Cracks

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In an October 5, 2020, Urgent Medical Device Field Corrective Action letter submitted by an ECRI member hospital, Bayer states that the above syringe kits may have a hole and/or crack, caused by a molding process problem. This problem may result in leakage of saline or contrast during loading, which may lead to injector malfunction and necessitate head replacement. Bayer also states that it has received no reports of patient or user injuries related to this problem and that testing does not indicate an increased patient safety risk associated with air injection. The manufacturer has not confirmed the...