Voluntary recall of Nova T Copper Intrauterine Device
Healthcare professional
Medical devices
29 January 2016
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Bayer (South East Asia) Pte Ltd would like to notify healthcare professionals of the recall of specific batches of Nova T Copper Intrauterine Device (T-shaped Copper IUD model with 200 mm2 copper surface) due to an increased device breakage rate. The breakage was noticed during or shortly after insertion in connection with expulsion of the T-body loop with attached threads. Investigations showed that the increased breakage rate can be traced back to a change in the T-body mould (due to a supplier change) in combination with the use of a specific raw material batch. Healthcare professionals are advised not to perform any further insertion of the affected batches and return them to Bayer. Please refer to the letter for details.
Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.
Step 1: Select your profession under ‘For Healthcare Professionals’.
Step 2: Click on ‘Useful links’.
Step 3: Click on ‘MOH Alert’ and log in via Singpass.
Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.
