Occlutech Sizing Balloon (2018-08-31)
- Starting date:
- August 31, 2018
- Posting date:
- September 17, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67762
Affected products
Occlutech Sizing Balloon
Reason
During the manufacturing step of "packaging and labeling" a mismatched Information For Use (IFU) was attached to some of the products from Lot B18007 (Article number REF 53SB355). Consequently, instead of the IFU for the Occlutech Sizing Balloon, the IFU for a completely different product has been attached to the product.
Affected products
Occlutech Sizing Balloon
Lot or serial number
B18007
Model or catalog number
53SB355
Companies
- Manufacturer
-
Occlutech GmbH
Winzerlaer Str. 2
Jena
07745
GERMANY