The FDA has issued early alerts for surgical convenience kits from Medical Action Industries and American Contract Systems tied to a recall of Medline Industries’ angiographic control syringes.
The affected kits contain Namic RA syringes, which may have a rotating adaptor that can unwind during use, leading to loose connections or disconnection between the syringe and manifold, according to April 16 agency notices. This can result in blood loss, infection, biohazard exposure or air embolism, which may lead to serious injury or death.
Medline reported four serious injuries and no deaths associated with the issue as of March 13.
Medical Action Industries and American Contract Systems notified customers March 13, March 19 and April 3, respectively, instructing them to identify, quarantine and relabel affected kits and remove and discard the syringes. The alerts cover multiple lot numbers across both companies’ products.
If use is unavoidable, Medline said the syringes should be used with extreme caution, including continuous monitoring and manual stabilization during procedures.
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