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Cadd High-Volume Administration Sets with Flowstop

by Deltec, Inc. 510(k)

Active United States Open recall

510(k) K031361

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK031361 Date23 May 2003ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-0962-2023 FDA Class I initiated 9 Dec 2022

    There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

    • Terminated Z-0148-2022 FDA Class II initiated 14 Jul 2020

    Product may have been manufactured with an air filter assembled in an incorrect orientation.

    • Terminated Z-2589-2017 FDA Class II initiated 15 May 2017

    One lot of CADD High Volume Administration sets, part number 21-7381-24, lot number 26X035, incorrectly contained the IFU insert for part number 21-7357-24.

Specification

510(k)

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

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