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ZESTICA OVULATION TEST AND CONCEPTION PACK (2015-12-21)
- Starting date:
- December 21, 2015
- Posting date:
- January 14, 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-56628
Affected Products
A. ZESTICA OVULATION TEST
B. ZESTICA CONCEPTION PACK
Reason
Unauthorised packaging and labelling activities were undertaken for Zestica Ovulation Test by the importer/distributor, Bescot Healthcare Canada Inc. The carton used in the packaging was from a previously expired lot with preprinted information (lot 20120915, expiry: 14/09/2014) on them. A stickered black-out label was placed on top of the preprinted information with new lot number and expiry date (lot 20140730 expiry 29/07/2016). The packaging and labelling activity for Zestica conception pack involved placing Zestica ovulation test kit and Zestica fertility lubricant (licence #87093), and IFU into a carton.
Affected products
A. ZESTICA OVULATION TEST
Lot or serial number
20140730
Model or catalog number
5060203270780
Companies
- Manufacturer
-
Burdica Biomed Ltd.
33 Research Ave. North
Edinburg
EH14 4AP
UNITED KINGDOM
B. ZESTICA CONCEPTION PACK
Lot or serial number
20140730
Model or catalog number
50602032270797
Companies
- Manufacturer
-
Burdica Biomed Ltd.
33 Research Ave. North
Edinburg
EH14 4AP
UNITED KINGDOM