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BD PhaSeal Closed System Transfer Device P55

by Becton, Dickinson and Company

510(k) K130197

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK130197 Date27 Feb 2013ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2453-2025 FDA Class II initiated 16 Jun 2025

    Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ONB
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BD PhaSeal Closed System Transfer Device P55 is a Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System. It is designed to facilitate the safe handling of hazardous and antineoplastic drugs by creating an airtight, leakproof barrier that prevents environmental contamination and drug vapor escape during transfer processes.

This device is intended for single-use in clinical settings, including general hospital environments. It is classified as a Class II medical device under FDA regulations and has received Special 510(k) clearance (K130197) for use in drug reconstitution and transfer procedures. The device is not MRI-compatible and must be stored in a clean, dry environment as per manufacturer guidelines.

From the manufacturer

Why are the PhaSeal™ System and SmartSite™ VialShield devices being discontinued? After careful consideration and in alignment with the BD commitment to innovation and safety, we have made the decision to retire the original PhaSeal™ Closed System Transfer Devices (CSTD) and the SmartSite™ VialShield Vial Access Devices.

Source: bd.com

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the BD PhaSeal Closed System Transfer Device P55, and why is it designed for single-use only?

    The BD PhaSeal Closed System Transfer Device P55 is designed to safely handle hazardous and antineoplastic drugs by creating an airtight, leakproof barrier during reconstitution and transfer processes. This prevents environmental contamination and drug vapor escape, protecting healthcare workers and patients. It is intended for single-use only because repeated use could compromise the integrity of the seal, increasing the risk of leaks, contamination, or exposure to hazardous substances. Single-use also aligns with infection control best practices in clinical settings.

  • How should the BD PhaSeal Closed System Transfer Device P55 be stored, and what environmental conditions are required?

    The device must be stored in a clean, dry environment as specified by the manufacturer. This ensures the integrity of the components and prevents degradation from moisture or contaminants. Avoid exposure to extreme temperatures, direct sunlight, or sources of electrostatic discharge, as these could compromise the device’s functionality or sterility.

  • Is the BD PhaSeal Closed System Transfer Device P55 compatible with MRI machines, and if not, why?

    No, the BD PhaSeal Closed System Transfer Device P55 is not MRI-compatible. This is explicitly stated in the manufacturer’s guidelines, likely due to the presence of materials or components that could interfere with MRI imaging or pose a safety risk in the magnetic field environment. Always verify compatibility with your facility’s MRI protocols before use.

  • What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its use in clinical settings?

    The BD PhaSeal Closed System Transfer Device P55 received Special 510(k) clearance (K130197) under the FDA’s premarket notification process. This classification means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness requirements for its intended use in drug reconstitution and transfer procedures in general hospital settings. The clearance confirms its compliance with FDA regulations for Class II medical devices.