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Baxter 1C8627

by Baxter Healthcare Corp GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 28 Oct 2026

Recall ongoing. 7 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00085412031859 UDI-DIDate24 Sep 2016ListedStatusIn distribution

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Recalls

12 recalls · 7 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-0194-2026 FDA Class II initiated 29 Aug 2025 via K203609, on the same 510(k)
    • Ongoing Z-0192-2026 FDA Class II initiated 29 Aug 2025 via K203609, on the same 510(k)
    • Ongoing Z-0193-2026 FDA Class II initiated 29 Aug 2025 via K203609, on the same 510(k)

    IV sets may leak.

    • Ongoing Z-2594-2025 FDA Class II initiated 8 Aug 2025

    Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.

    • Ongoing Z-1011-2025 FDA Class II initiated 20 Dec 2024

    Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

  • 2 recalls, same reason

    • Ongoing Z-0794-2020 FDA Class II initiated 12 Dec 2019
    • Ongoing Z-0793-2020 FDA Class II initiated 12 Dec 2019

    Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.

    • Terminated Z-0475-2012 FDA Unclassified (pre-2012) initiated 6 Dec 2011

    During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection.

    • Terminated Z-2920-2011 FDA Unclassified (pre-2012) initiated 21 Jul 2011

    The Solution Sets are being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient.

    • Terminated Z-0653-06 FDA Unclassified (pre-2012) initiated 15 Dec 2005 via K961225, on the same 510(k)

    The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.

    • Terminated Z-0845-05 FDA Unclassified (pre-2012) initiated 28 Feb 2005

    Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve.

    • Terminated Z-1152-03 FDA Unclassified (pre-2012) initiated 16 Jul 2003

    There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

GUDID

Trade Name
Baxter
Generic Name
Basic intravenous administration set, noninvasive
Model / Ref / Catalog
1C8627
Primary DI / UDI-DI
00085412031859
510(k) Number
FDA Product Code
FPA
GMDN Term
Basic intravenous administration set, noninvasive
Device Class
Class II
Regulation Number
880.5440
Commercial Distribution
In Commercial Distribution

Related devices

Category: Basic intravenous administration set, noninvasive

Cleared under the same submission (K203609)

Show all (12)

Cleared under the same submission (K961225)

Show all (12)

Other devices from Baxter Healthcare Corp

See all devices from Baxter Healthcare Corp →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No