Health product recall

Neuro-Fiberscope (2019-08-23)

Starting date:
August 23, 2019
Posting date:
September 12, 2019
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-70961

Last updated: 2019-09-12

Affected Products

Neuro-Fiberscope

Reason

During a complaint investigation the device instruction manual was reviewed and an error was noticed. For Steris SS1 E process, the quick connector kit model number and the associated tray number listed in the manual were incorrect. A further step was taken to review all flexible scope instruction manuals and found the error in other manuals as well.

Affected products

Neuro-Fiberscope

Lot or serial number

All lots. 

Model or catalog number

11161C2
11282BN1

Companies
Manufacturer

KARL STORZ SE & CO. KG

DR.-KARL-STORZ STRASSE 34

TUTTLINGEN

78532

GERMANY