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Alaris 9601

by CareFusion 303, INC GUDID

Listed FDA GUDID listing, not in commercial distribution Open recall

Regulatory status

as of 28 Oct 2026

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885403960109 UDI-DIDate8 Dec 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

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

GUDID

Trade Name
Alaris
Generic Name
Infusion pump medication-dosage application software
Model / Reference
9601
Primary DI / UDI-DI
10885403960109
510(k) Number
FDA Product Code
FRN
GMDN Term
Infusion pump medication-dosage application software
Device Class
Class II
Regulation Number
880.5725
GUDID distribution status
Not in Commercial Distribution

Other devices from CareFusion 303, INC

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Properties

Other properties (14)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No