Quality Flaws Trigger Massive Recall, Operations Stoppage

 

Nov 06, 2017

Perhaps the two industries most notoriously connected to recall headlines are the automotive and food sectors. However, this past week offered a look at how product defects had huge impacts on the medical and safety markets.

First, North Carolina-based fire extinguisher maker Kidde recalled over 40 million fire extinguishers covering 134 models that were produced over a 44-year span.

The U.S. Consumer Product Safety Commission (CPSC) prompted the recall after investigations stemming from a fatal car fire three years ago revealed that the units could become clogged and fail to activate, or the nozzle can actually detach from the extinguisher with enough force to pose an impact hazard.

Kidde also recognized 391 reports of failed or limited activation, as well as nozzle detachment that led to 16 injuries and 91 reports of property damage. The Canadian government recently added 2.7 million units to the recall. Kidde is offering replacements instead of refunds.

In another example, the largest manufacturer of automated external defibrillators announced this past week that it must cease production of the units after the Food & Drug Administration (FDA) found Philips Medical Systems in violation of Good Manufacturing Practices. The nature of the situation doesn’t dictate a recall, but Philips must notify users of the equipment in question.

According to the company’s website, the FDA is concerned about a component that can result in the defibrillators failing to deliver the proper number of electrical shocks. Of the 650,000 units shipped with this component, Philips acknowledged being aware of 12 instances in which the AED didn’t perform as needed, but did deliver at least one shock.

Philips holds a 50 percent global market share for public access defibrillators. The FDA claims the company distributed flawed products that put people at risk by failing "to establish and maintain adequate processes regarding its corrective and preventive action procedures, as well as validation controls."

The facilities in Andover, Massachusetts, and Bothell, Washington will not be allowed to resume operations until a qualified third-party expert verifies that the quality systems are in compliance and they can pass an FDA inspection.