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HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML - 15ML

by Teleflexmedical, Inc.

510(k) K142153

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 NumberK142153 Date29 Apr 2015ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2514-2023 FDA Class I initiated 4 Aug 2023

    Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.

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  • Withdrawn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
CAF
Models / Variants
15ML
Device Class
Class II
Regulation
21 CFR Part 868.5630
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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