PENTAX Video Duodenoscope (2018-07-20)

Starting date:

July 20, 2018

Posting date:

August 2, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67346

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  Reason
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  Affected products

Affected products

PENTAX Video Duodenoscope

Reason

The complex design of duodenoscopes, including the ED34-i10T, requires meticulous cleaning for effective reprocessing. The US FDA evaluated elevator channel sealing for all duodenoscopes, and required that o-ring compression be increased for all duodenoscopes to be distributed in the US.

PENTAX has made minor design changes in response to this initiative, which are also being made to ED34-i10T units in Canada.

Affected products