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Becton Dickinson 360 Infuser (Tm) System

by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)

Active United States Open recall (shared submission)

510(k) K902409

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall on shared 510(k) K902409: the recalled product is another device cleared under the same submission. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK902409 Date19 Jul 1990ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2176-2025 FDA Class I initiated 9 Jul 2025 on shared 510(k) K902409

    Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common to air eliminating filters.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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