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Alaris System with Mms, Model 8XXX

by Cardinal Health 303, Inc. 510(k)

Active United States Open recall

510(k) K072105

Regulatory status

as of 29 Oct 2026

Recall ongoing. 5 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK072105 Date28 Dec 2007ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

5 recalls · 5 ongoing · FDA

    • Ongoing Z-1645-2026 FDA Class II initiated 11 Feb 2026

    Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

  • 3 recalls, same reason

    • Ongoing Z-0185-2024 FDA Class I initiated 15 Sep 2023
    • Ongoing Z-0184-2024 FDA Class I initiated 15 Sep 2023
    • Ongoing Z-0186-2024 FDA Class I initiated 15 Sep 2023

    Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

    • Ongoing Z-1192-2023 FDA Class II initiated 24 Jan 2023

    Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to transfer retrospective analytics data to connected systems. Users with interfaces to electronic medication record or admin discharge transfer, may be unable to receive/send data; infusions may need to be manually programmed

Specification

510(k)

510(k) Number
FDA Product Code
FRN
FDA applicant
Cardinal Health 303,Inc.
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Cardinal Health 303, Inc.