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LiNA Librata-Endometrial Ablation Device (2017-10-06)
- Starting date:
- October 6, 2017
- Posting date:
- October 20, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-64902
Affected products
LiNA Librata-Endometrial Ablation Device
Reason
Glycerin leaks from Librata's devices were observed during the sterilization process which may have an impact on device sterility and functionality.
Affected products
LiNA Librata-Endometrial Ablation Device
Lot or serial number
- 1727031
- 1728004
Model or catalog number
LIB-1
Companies
- Manufacturer
-
Lina Medical APS
Formervangen 5 Glostrup,Denmark, 2600
Glostrup
DENMARK