The Central Drugs Standard Control Organization (CDSCO) has issued a notice regarding a voluntary recall of Tisseel LYO Fibrin Sealant Kits manufactured by Takeda Manufacturing Austria AG. This public notice was issued on September 2, 2024.
The recall is due to extended dissolution time of the sealer protein concentrate observed during stability studies at storage temperature of 25 degrees celcius.
Hazard Involved
According to the drug recall intimation by Baxter, if the sealer protein concentrate is insufficiently dissolved, intraoperative delay in therapy could result while a fresh kit is being prepared. The likelihood that this would lead to harm for the patient is remote as Tisseel is an adjunct to hemostasis and sealing. Furthermore, as shown in laboratory testing, the product is still usable and effective even if the sealer protein is not completely dissolved. Tisseel is intended for epilesional use only; it is not to be used intravascularly.
Affected Products
- Generic Product Name: Fibrin Sealant VHS/D powder and solvent for Sealant I.P.
- Name: Tisseel LYO
- Pack Size: 4 ml and 10 ml
- Affected Batch Numbers: T54010AA, T5A047AC, T5X053AD, T5X056AD, T5X075AA and T5X036AE
Recall Details
- Reason for Recall: Extended dissolution time of the sealer protein concentrate.
- Affected Quantity: The recall affects a total of 10,677 units of the product.
- Replacement Kits: The firm does not have replacement kits available for the recalled products.
Actions to be taken by Customers
- Healthcare providers may continue to safely use the products if the fibrin sealant is prepared in advance to ensure it is fully dissolved and ready to be used when needed. If the Sealer Protein Concentrate has not fully dissolved, discard the vial, and prepare a fresh kit.
- If a customer has unused Tisseel Fibrin Sealant Kits that they would like to return, they are requested to contact Baxter Healthcare Center for Service to arrange for return and credit.
- Once Baxter has implemented corrective actions to resolve the issue, a follow-up notification will be sent to customers to provide additional instructions.
- If you purchased this product directly from Baxter, complete the Baxter Customer Reply Form and return it to Baxter by scanning and e-mailing it to Baxter sales team or India product complaints@baxter.com.
