Pentax Recalls Duodenoscope Model

Feb 08, 2018 - 12:52 PM

Pentax Medical yesterday recalled its ED-3490TK duodenoscope model to replace certain parts and update the operations manual. The design changes were approved by the Food and Drug Administration, which recommends that customers acknowledge receipt of the Pentax recall notice, return the response form and dispose of older operations manuals when they receive the new one. They also should continue to use the model’s revised manual reprocessing instructions. 

Related News Articles

Headline
AHA’s Pollack details significant progress hospitals have made improving patient safety
AHA President and CEO Rick Pollack explains how hospitals have made meaningful progress in patient safety and delivering high-quality care, in a column…
Headline
FDA issues most serious recall for two Smiths Medical infusion pumps
The Food and Drug Administration issued Class I recalls, the most serious type, for two Smiths Medical infusion pumps due to the potential for serious injury…
Headline
AHA makes 100 suggestions to Trump administration on providing regulatory relief 
The AHA May 12 responded to the Office of Management and Budget's April 11 request for information on regulatory relief, making 100 suggestions to the Trump…
Headline
FDA announces recall for certain IV bags
The Food and Drug Administration published a notice from Amneal Pharmaceutical that said the company is recalling two lots of its Ropivacaine Hydrochloride…
Headline
Recall issued for aspiration system by Q’Apel Medical
The Food and Drug Administration has identified a Class I recall of Q’Apel Medical 072 Aspiration System after the company submitted three device event reports…
Headline
FDA issues alerts on certain catheters produced by BD, Conavi
The Food and Drug Administration has issued alerts for issues with certain catheters made by BD and Conavi. BD identified an increase in material fatigue…