Health product recall

Pentax Duodenoscope & Medical Single Use, Sterile Distal End Cap with Elevator (2021-04-30)

Starting date:
April 30, 2021
Posting date:
May 13, 2021
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-75569

Last updated:
2021-05-13

Affected Products 

A. Pentax Duodenoscope
B. PENTAX MEDICAL SINGLE USE, STERILE DISTAL END CAP WITH ELEVATOR

Reason

The recall was identified by Pentax Medical in the US. Multiple customer complaints were received in relation to the OE-A63 (Single-Use Sterile Distal End Cap with Elevator from the ED34-i10T2 duodenoscope) unexpectedly falling off of the duodenoscope during procedures.

Affected products

A. Pentax Duodenoscope

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

ED32-I10
ED34-I10T2

Companies
Manufacturer

Hoya Corporation

6-10-1 NISHI-SHINJUKU

Shinjuku-ku

160-0023

JAPAN

B. PENTAX MEDICAL SINGLE USE, STERILE DISTAL END CAP WITH ELEVATOR

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

OE-A63
OE-A65

Companies
Manufacturer

Hoya Corporation

6-10-1 NISHI-SHINJUKU

Shinjuku-ku

160-0023

JAPAN