Takeda Korea said it has begun replacing Baxject II reconstitution devices for hemophilia A treatment Advate Inj. and hemophilia B treatment Rixubis Inj. after finding plastic inside some of the devices.

According to the Ministry of Food and Drug Safety (MFDS), the matter came to light after Takeda Korea filed a quality abnormality report for plastic pieces found in the reconstitution devices.

Takeda Korea is replacing the reconstitution devices with new devices for the products manufactured from October 2021 to January 2022.

The MFDS has also distributed a safety letter to healthcare professionals and patients with the manufacturer's number of the product in question, advising them to discard the device and use a new one if they have the product.

"Takeda Korea is voluntarily replacing Baxject II reconstitution devices produced by the contract manufacturer between October 2021 and January 2022, and co-packaged for use in conjunction with Rixubis and Adavate,” a Takeda Korea spokesperson told Korea Biomedical Review. “This is a precautionary measure due to reports of plastic particles that originated in the luer port of the device.”

The particle size that has been observed is larger than the diameter of the needle, making it unlikely due to the difficulty of its size to pass through the narrow lumen of the syringe, she added.

The spokesperson said the safety and efficacy profiles of the two drugs remain consistent with the product labels.

“We sincerely regret the impact this device replacement may have on patients, and Takeda is committed to providing reliable and high-quality therapies for patients by communicating closely with regulatory authorities, medical experts, patient group, and industry traders,” she said.