Terumo Syringe, 50 mL, Model BS-50LB

No FDA recalls found in the data synced 22 Oct 2026.

Full name

50 Ml Terumo Syringe for Administration of UV Sensitive Medicines, Model Bs-50LB

510(k) Number

K070264 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Terumo Europe N.V. →

• What is the Terumo BS-50LB syringe specifically designed for?

  The Terumo BS-50LB syringe is designed for the administration of ultraviolet-sensitive medicines. Its primary purpose is to protect these medications from degradation caused by light exposure during aspiration or injection. This makes it particularly useful in clinical settings where light-sensitive drugs—such as certain chemotherapy agents or biologics—require careful handling to maintain efficacy.

• Is the Terumo BS-50LB syringe reusable or single-use?

  The Terumo BS-50LB syringe is a single-use device. This design choice ensures sterility and safety for each patient, reducing the risk of contamination or cross-infection. Single-use syringes are also aligned with best practices for infection control in healthcare environments, particularly in hospital settings where precision and reliability are critical.

• How should the Terumo BS-50LB syringe be stored to maintain its integrity?

  The Terumo BS-50LB syringe must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Typically, this involves keeping it in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Exposure to light, moisture, or contaminants can compromise the syringe’s sterility or the integrity of its components, so adherence to storage recommendations is essential before use.

• What capacity does the Terumo BS-50LB syringe have, and what types of fluids can it handle?

  The Terumo BS-50LB syringe has a capacity of 50 mL, making it suitable for administering larger volumes of fluids compared to standard syringes. It is designed for precise aspiration or injection of a variety of fluids, including blood and ultraviolet-sensitive medications. Its larger volume allows for accurate dosing of drugs that require higher volumes, such as certain intravenous infusions or chemotherapy agents, while minimizing the risk of light-induced degradation.

• Why is light protection important when using this syringe?

  Light protection is critical when administering ultraviolet-sensitive medicines because exposure to light—particularly ultraviolet (UV) radiation—can degrade the chemical structure of these drugs. This degradation can reduce their potency, alter their pharmacological effects, or even render them ineffective. The Terumo BS-50LB syringe is engineered to mitigate this risk by shielding the medication from light during handling and administration, ensuring the drug remains stable and effective for the patient.