Teleflex announced the worldwide voluntary recall of Hudson RCI Pediatric Anesthesia Breathing Circuits, which the U.S. Food and Drug Administration has classified as a Class 1 recall.
The FDA defines Class I recalls as, "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
Teleflex is recalling the products due to complaints it has received that the ends of the pediatric breathing circuits can crack before and during use. There have been no reports of patient injury as a result of this issue.
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The FDA defines Class I recalls as, "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
Teleflex is recalling the products due to complaints it has received that the ends of the pediatric breathing circuits can crack before and during use. There have been no reports of patient injury as a result of this issue.
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