Q3 Recalls Snapshot: Number Of Recalls Ticks Up For Third Consecutive Quarter; Recalled Units Spike An Incredible 1013%
Device makers initiated 243 recalls in the third quarter of 2019 – a modest 1% increase over Q2’s 200 recalls. Interestingly, the number of recalled device units skyrocketed a whopping 1013%, from 19.7 million in Q2 to 219.2 million in Q3. Check out our Q3 recalls infographic.
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Q2 Recalls Snapshot: It's A Mixed Bag For Industry As Recall Events Jump Slightly And Recalled Units Fall Dramatically
There were 200 recalls initiated by device-makers in the second quarter of 2019, a 22% increase over Q1, when 164 were reported. Conversely, the number of recalled device units fell from 135 million in Q1 to 19.7 million in Q2 – a decrease of 85%. Check out our Q2 recalls infographic.
Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 4)
A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this fourth installment of a 10-part series, the experts address so-called back rooms used by manufacturers during an inspection.
‘Immediately Discontinue’ Using Potentially Nonsterile Surgical Gowns, Packs From Cardinal Health, FDA Warns; Company Assessing Quality Issues
The US agency is telling health-care providers to yank specific gowns – and procedural packs that contain the gowns – from shelves because their maker, Cardinal Health Inc., cannot assure their sterility. The agency is also warning that the problem could lead to a shortage of so-called Level 3 gowns, which are used in a wide-array of everyday surgical procedures.