Baxter Healthcare issues Voluntary Recall for Tisseel LYO Fibrin Sealant Kits Over Quality Concerns
New Delhi: The Drug Controller General of India has issued a notice regarding the urgent voluntary recall made by Baxter Healthcare for the 4 mL and 10 mL Tisseel Fibrin Sealant Kits (commonly referred to as Tisseel Lyo Fibrin Sealant) due to the extended dissolution time of the sealer protein concentrate, observed during stability studies at a storage temperature of 25 °C.
The batch numbers of T5A010AA, T5A047AC, T5X053AD, T5X056AD, and T5X075AA for the Fibrin Sealant VHS/D powder and solvent for Sealant I.P. 4 ml and T5X036AE for the Fibrin Sealant VHS/D powder and solvent for Sealant 10 ml are affected.
Fibrin Sealant VHS/D powder and solvent for Sealant I.P. (Tisseel LYO) were imported from the manufacturing facility Takeda Manufacturing Austria AG, lndustriestrasse 67, A-1221, Vienna, Austria.
TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when controlling bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.
Describing the problem, Baxter Healthcare issued an urgent drug recall for the 4 mL and 10 mL Tisseel Fibrin Sealant Kits (commonly referred to as Tisseel Lyo Fibrin Sealant) due to extended dissolution time of the sealer protein concentrate observed during stability studies at a storage temperature of 25 °C.
Furthermore, Baxter Healthcare mentioned, "All other quality parameters (chemical and physical) comply with product specifications and no instances have been observed during testing where the Sealer Protein concentrate does not completely dissolve. The portion of the product that took longer to dissolve was approximately 1% and consists of fibrinogen, human albumin, and fibronectin, which are all part of the product composition."
In addition, the firm further added that Baxter does not have replacement kits for the 4 mL and 10 mL Tisseel Lyo Tisseel Fibrin Sealant kits.
'Healthcare providers may continue to safely use the products listed below 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 within 20 minutes, discard the vial, and prepare a fresh kit.' the firm added.
In addition, explaining the hazards involved, Baxter Healthcare stated, "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."
The impacted lot detail is as below:
Product Code | Product Name | Pack size | Affected Batch No | Quantity Imported | Quantity Available Warehouse |
1504384 | Fibrin Sealant VHS/D powder and solvent for Sealant I.P | 4 ml | T5A010AA T5A047AC T5X053AD T5X056AD T5X075AA | 3112 2685 3120 3120 3119 | 500 |
1505816 | Fibrin Sealant VHS/D powder and solvent for Sealant I.P | 10ml | T5X036AE | 62 | 43 |
1. Healthcare providers may continue safely using the products listed above if the fibrin sealant is prepared in advance to ensure it is fully dissolved and ready to be used. If the Sealer Protein Concentrate has not fully dissolved, discard the vial, and prepare a fresh kit.
2. If you have unused Tisseel Fibrin Sealant Kits that you would like to return, contact Baxter Healthcare Center for Service to arrange for return and credit.
3. Once Baxter has implemented corrective actions to resolve the issue, a follow-up notification will be sent to customers to provide additional instructions.
4. If you purchased this product directly from Baxter, complete the enclosed Baxter Customer Reply Form and return it by scanning and e-mailing it to Baxter sales team or India product complaints@baxter.com. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices.
However, the firm notified that as of 05122/2024, Baxter has not received any confirmed complaints or adverse events reported associated with this issue on the impacted products.
To view the official notice, click the link below:
