Recall of SurgiMend® and PriMatrix® products due to issues with the in-process and finished goods endotoxin testing
Humedical (S) Pte Ltd has issued a communication directed at healthcare professionals. This letter serves to notify healthcare professionals about identified issues related to the endotoxin testing of both in-process and finished goods. These issues have the potential to yield endotoxin results that fall outside acceptable specifications. The products affected by this matter include SurgiMend®, SurgiMend® MP, SurgiMend® PRS, SurgiMend® PRS Meshed, PriMatrix® Dermal Repair Scaffold, and PriMatrix® Ag Antimicrobial Dermal Repair Scaffold.
Possible adverse consequences stemming from elevated endotoxin levels encompass mild symptoms such as low-grade fever, inflammation, and/or an inflammatory response leading to fever (pyrexia), as well as the possibility of necessitating surgical intervention or revision surgery.
Healthcare professionals are strongly recommended to assess their inventories, isolate any affected products, and promptly return them. Additionally, they should closely monitor patients who have received these products and make treatment decisions based on their clinical judgment and the symptoms exhibited by the patients.
Link to the HSA announcement: https://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/recall-of-surgimend-and-primatrix-products-due-to-issues-with-the-in-process-and-finished-goods-endotoxin-testing
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