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- Medtronic recalls Harmony delivery catheter system after tip detachment riskMedtronic has issued a recall of certain lots of its Harmony Delivery Catheter System (DCS), which is used to implant the Harmony transcatheter pulmonary valve. The FDA classified the recall as th…
- FDA issues early alert on non‑sterile BD ChloraPrep applicators in Medline convenience kitsFDA CDRH issued an early alert about a potentially high‑risk device issue involving BD ChloraPrep applicators in Medline convenience kits that may not be sterile. Medline sent a letter on June 12…fda medwatch · 1mo agoRegulatoryNegative