Smiths Medical has issued an urgent medical device correction for certain sizes of its Portex intubation oral/nasal endotracheal tubes due to a manufacturer defect that results in a smaller-than-expected diameter.
Category: Supply Chain
FDA warns Dexcom over 2 site deficiences
Dexcom, a medical device manufacturer that develops continuous glucose monitoring systems, received a warning letter from the FDA regarding manufacturing processes at its facilities in San Diego and Mesa, Ariz.
41% of Americans believe Trump administration is bringing the ‘right change’ to tariffs
New tariffs levied against major U.S. trade partners including Mexico, Canada, China and the EU are affecting nearly all industries and consumers nationwide, and the medical device industry is no exception. President Donald Trump’s tariff plan was expected to affect the prices of approximately 75% of medical devices marketed in the U.S., according to a […]
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3 medical device recalls and corrections
Medical device recalls are essential to patient safety, addressing critical issues in devices that may pose health risks.
1 in 3 FDA safety reports filed late or with missing, invalid dates
A new study analyzing the FDA’s Manufacturer and User Facility Device Experience database found that nearly one-third of medical device safety reports were not submitted within the 30-day timeframe or had “missing or invalid date data,” according to th…
GOP House leaders block vote to end Trump tariffs: 4 things to know
House Republican leaders took steps this week to prevent a vote on ending President Donald Trump’s tariffs on Mexico, Canada and China, The New York Times reported March 11.
3 executives plead guilty to hiding medical device defect
Three former executives of Magellan Diagnostics, a North Billerica, Mass.-based medical device company, have pleaded guilty to charges related to concealing a malfunction in lead-testing devices that produced inaccurately low results for thousands of c…
How supply chain, C-suite executives see their roles in growth: 4 takeaways
A new survey from LeanDNA, a software and analytics company, highlighted a communication gap between C-suite executives and supply chain leaders, which may be limiting growth.
GHX bestows 2024 'Supply Chains of Distinction' honors
The Supply Chains of Distinction Award honors GHX Exchange-connected healthcare provider organizations that have demonstrated top-tier efficiency by excelling in perfect order metrics throughout the calendar year, according to a company announcement.&n…
Baxter recalls Spectrum infusion pumps
Baxter Healthcare has issued a recall for some Spectrum infusion pumps due to a potential defect involving missing motor mounting screws, which could lead to interruptions, delays or incorrect dosing of medication.
