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NidOil (2015-12-03)
- Starting date:
- December 3, 2015
- Posting date:
- January 7, 2016
- 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-56546
Affected Products
A. NidOil
Reason
Manufacturer has received a report from a customer with observations of reduced development of some of the embryos day 5-6 in cultures covered with NidOil, batch number: 100NOVI15. The risk for a patient is indirect in the IVF treatment. The potential hazard would be reduced development in the embryos.
Affected products
A. NidOil
Lot or serial number
100NOVI15
Model or catalog number
NO-100
Companies
- Manufacturer
-
NIDACON INTERNATIONAL AB
FLOJELBERGSGATAN 16B
MOLNDAL
43137
SWEDEN