Dear Healthcare Professional Letters
Recall of B. Braun Gelita-Tampon® Absorbable Gelatin Sponge
Audiences
Healthcare professional
Industry member
Product type
Medical devices
10 October 2022
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A Dear Healthcare Professional Letter has been issued by B. Braun Singapore Pte Ltd to inform healthcare professionals of a recall of all batches of the B. Braun Gelita-Tampon® Absorbable Gelatin Sponge that are still within the shelf life. This recall is due to endotoxin concentration of the product that was measured to be above the limit in some samples during a routine bioburden testing. The use of the affected products could potentially cause an acute pyrogenic reaction within two to five days after use. Healthcare professionals are advised to immediately quarantine and return all the affected products. For patients who present with complication from use of the affected products, healthcare professionals are advised to follow the hospital protocol for such situations. 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.