FDA Classifies Recall of Alaris PC Units Model 8015 as Class I Recall

  • Date: December 01, 2010
  • Source: Admin

The FDA has classified CareFusion’s decision to recall approximately 17,000 Alaris® PC units (model 8015) which had been manufactured or serviced between December 2008 and September 2009 as Class I recall. CareFusion (denoted as CFN in the NYSE) is a leading global medical device company. The FDA classifies the recall of those items as Class I recall when there is substantial possibility that the use or exposure to the product will call serious health hazards or even death.

CareFusion, on August 24, 2010, issued an urgent Medical Device Recall Notification to the customers of its Alaris PC unit model 8015. The Notification stated that the affected units may face certain intermittent error in communication under specific wireless network conditions. This would freezes the PC unit screen and finally result in a delay in therapy and the inability in making programming changes to the current infusions. If there is a communication during infusion, the infusion would continue on all channels, as has been programmed originally, but it cannot be modified. Halting the infusion, as a result of this error, to make any modification or changes in programming causes the unit to shut down delaying the therapy. This can cause serious injury or even death.

CarreFusion is still in the process of conducting a corrective action plan to rectify the problems in the hardware of the affected PC units. In the Notification issue, the customers were provided with clinical tip sheets and informed of warning tags for each affected units. Customers were also provided with instructions on the method of temporarily or permanently disabling the wireless mode of the PC unit so as to further allay the risk of serious injury.

Recent Incidents

In a recent incident reported in September, the FDA classified another recall of certain makes of AngioSculpt PTCA Scoring Balloon Catheter as Class I recall. This recall applied only to EX catheters — to those with part/REF numbers 2034-XXYY and lot numbers less than F09060003. In December 2009, the manufacturer had informed customers that the PTCA catheters may disintegrate during use and get lodged in the coronary arteries.

What is Class I Recall?

In must be mentioned here that all recalls by manufacturers are categorised by FDA as Class I, Class II or Class III recall based on level of health hazard involved. While in some cases, the manufacturing company itself discovers the snag the product and recalls it from the market, in others, FDA informs the company concerned of its findings on a product and suggests a recall with which the company usually complies. In case the company does not recall, the FDA is authorised to seek legal action under the provisions of the FD&C Act.


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