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Alaris 8961

by CareFusion 303, INC 2 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

5 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885403896101 UDI-DI Date8 Dec 2016ListedStatusListed GUDID: not in commercial distribution

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Alaris
Generic Name
Infusion pump medication-dosage application software
Model / Reference
8961
Primary DI / UDI-DI
10885403896101
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

See all devices from CareFusion 303, INC →

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