Product Wiki · Recalls · Health Canada — Medical Devices

ZESTICA OVULATION TEST AND CONCEPTION PACK (2015-12-21) — recall 54236

Health Canada — Medical Devices · Canada · 2016-01-14 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54236
Date of alert
2016-01-14
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/zestica-ovulation-test-and-con

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