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0.9% Sodium Chloride Injection, USP

by Medline Industries, Inc.

510(k) K173348

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 · Traditional NumberK173348 Date21 Jun 2018ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0234-2026 FDA Class II initiated 11 Sep 2025

    Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.

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  • Withdrawn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
NGT
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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