SFDA National Center for Medical Devices Reporting

X

Your changes have been successfully saved

Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home Published FSNs/Recalls About NCMDR Contact Us FAQ Login

NCAR Recall

Back

Reference Number:	mdprc 084 02 12 000
Date submitted:	2/14/2012

Manufacturer:	Cook Medical
Device Type:	In vitro fertilization culture medium kit
Description:	In vitro, Oil, kit
Medical Device Identifier:	K-SICO & K-SICO, Sydney IVF Culture Oil, (K-StCO-200), (K-SrCO-50) Lot Numbers: attached
Reason of Field Safety Corrective Action:	The devices are being recalled due to a potential contamination that could cause embryo degeneration at day 5/ 6. Additional testing by the manufacturer on recently manufactured batches of culture oil showed a peroxide level that a literature report suggests could cause embryo degeneration
Remedy Action:	Sponsor advises that there are no additional risks associated with this issue other than the known risks associated with assisted reproductive technology due to failure at day 5/6 that may necessitate additional cycles of treatment on the part of the potential mother. The patient is not directly contacted or affected by the product. All products released to the field met the release specifications, including Mouse Embryo Assay. destroy any affected product.
Athorized Representative/Importer/Distributor:	NAFA Medical , Riyadh , (01)4708888
Report Source:	NCAR
Source Ref. Number:	AU-2012-02-10-001
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Code Information- Cook Medical.pdf

View History