Medline Industries has recalled medical convenience kits due to a syringe defect.
The recall, initiated Feb. 27, affects 966 kits that include Namic angiographic rotating adaptor control syringes used in labor and delivery settings, according to an April 7 FDA enforcement report.
Medline identified a risk that the syringe’s rotating adaptor could unwind during use, potentially causing a loose connection or complete disconnection between the syringe and manifold.
The FDA classified the recall as Class I, its most serious designation, indicating a risk of serious adverse health consequences or death.
Medline instructed customers to remove and discard affected components and quarantine impacted inventory. The products were distributed nationwide and internationally.
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