Last Updated on September 30, 2024 by The Health Master
Drug recall
Baxter, a leading global healthcare company, has issued a voluntary drug recall for certain batches of its imported fibrin sealant, Tisseel LYO.
The drug recall is due to concerns about the dissolution time of the sealer protein concentrate, which could potentially lead to delays in surgical procedures.
The Drug Recall Details
The affected products are Tisseel Fibrin Sealant Kits in 4 ml and 10 ml sizes.
The drug recall involves six batches of the 4 ml kit and one batch of the 10 ml kit.
The issue was discovered during stability studies conducted at a storage temperature of 25 degrees Celsius.
Potential Risks and Safety Measures
If the sealer protein concentrate is not fully dissolved, it could delay surgical procedures.
However, Baxter emphasizes that the risk of harm to patients is low as Tisseel is primarily used as an adjunct to hemostasis and sealing.
To minimize any potential risks, Baxter recommends that healthcare providers:
- Prepare the fibrin sealant in advance: Ensure that the sealer protein concentrate is fully dissolved before use.
- Discard vials if necessary: If the sealer protein concentrate has not fully dissolved within 20 minutes, discard the vial and prepare a fresh kit.
Consumer Actions
Consumers with unused Tisseel LYO kits can contact the Baxter Healthcare Centre for service to arrange for return and credit.
Baxter will provide a follow-up notification once corrective actions have been implemented.
Previous Drug Recall by Health Canada
In May 2024, Health Canada also announced a drug recall of Tisseel kits by Baxter due to dissolution time issues.
This previous drug recall highlights the importance of ongoing quality control measures in the healthcare industry.
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Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.
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