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