Flexible Intubation Endoscopes (2020-07-27)
- Starting date:
- July 27, 2020
- Posting date:
- August 28, 2020
- 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-73769
Last updated:
2020-08-28
Affected Products
- Flexible Intubation Endoscopes
- Flexible Intubation Endoscopes
Reason
A labeling correction for 8 models of scopes to provide updated sterilization instructions to users based on currently available laboratory validation studies for sterrad and eto modalities.
Affected products
A. Flexible Intubation Endoscopes
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 11301BN1
- 11301BND1
- 11303BNX
Companies
- Manufacturer
-
KARL STORZ SE & CO. KG
DR.-KARL-STORZ STRASSE 34
TUTTLINGEN
78532
GERMANY
B. Flexible Intubation Endoscopes
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 11301AA1
- 11301BNX
- 11302BD2
- 11302BDD2
- 11302BDX
Companies
- Manufacturer
-
KARL STORZ SE & CO. KG
DR.-KARL-STORZ STRASSE 34
TUTTLINGEN
78532
GERMANY