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Health Sciences Authority
Dear Healthcare Professional Letters

Recall of selected lots of Baxter Healthcare COSEAL Surgical Sealant due to potential incomplete dissolution of the polyethylene glycol (PEG) component

Audiences

Healthcare professional

Product type

Medical devices

9 June 2016

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Baxter Healthcare (Asia) Pte Ltd would like to inform healthcare professionals of a voluntary recall of selected lots of COSEAL Surgical Sealant due to the potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use. This issue was identified as a result of an increase in complaints for COSEAL overseas. Healthcare professionals are advised not to use the affected products and return them to Baxter Healthcare (Asia) Pte Ltd. 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 (opens in new tab) 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.