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Exactamix H938174

by Baxter Healthcare Corp

Exactamix H938174 is a Class II device made by Baxter Healthcare Corp, cleared under FDA 510(k) K002705 on 28 Mar 2001 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00085412475790), active as of 23 Oct 2026. 15 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

8 ongoing

This device is named in the recall

Documents

510(k) K002705

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00085412475790 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK002705 Date28 Mar 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K002705 decided 28 Mar 2001 Active
  • FDA GUDID UDI-DI 00085412475790 listed 23 Sep 2016 Listed

Recalls

15 recalls · 8 ongoing · FDA

    • Ongoing Z-2262-2026 FDA Class II initiated 22 Apr 2026

    Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc.

  • 4 recalls, same reason

    • Ongoing Z-3084-2024 FDA Class I initiated 20 Aug 2024
    • Ongoing Z-3082-2024 FDA Class I initiated 20 Aug 2024
    • Ongoing Z-3083-2024 FDA Class I initiated 20 Aug 2024
    • Ongoing Z-3085-2024 FDA Class I initiated 20 Aug 2024

    Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.

  • 2 recalls, same reason

    • Ongoing Z-1002-2024 FDA Class I initiated 22 Dec 2023
    • Ongoing Z-1001-2024 FDA Class I initiated 22 Dec 2023

    An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.

    • Ongoing Z-1570-2022 FDA Class II initiated 14 Jul 2022

    There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.

  • 4 recalls, same reason

    • Terminated Z-1908-2018 FDA Class II initiated 25 Apr 2018
    • Terminated Z-1911-2018 FDA Class II initiated 25 Apr 2018
    • Terminated Z-1910-2018 FDA Class II initiated 25 Apr 2018
    • Terminated Z-1909-2018 FDA Class II initiated 25 Apr 2018

    Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,

    • Terminated Z-1752-2013 FDA Class II initiated 4 Jun 2013

    Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complementary metal oxide semi-conductor battery failure resulting in resetting the internal clock of the device to midnight December 31, 2010.

    • Terminated Z-1197-2010 FDA Unclassified (pre-2012) initiated 10 Feb 2010

    Molding defect in the valve body causes leaking.

    • Terminated Z-0210-04 FDA Unclassified (pre-2012) initiated 7 Nov 2003

    If device stops due to an alarm or operater pause, inlet valves will remain open, allowing some unwanted mixing of ingredients in the valve chamber..

Timeline

17 dated events

  1. Recall initiated FDA recalls Z-1910-2018
  2. Recall initiated FDA recalls Z-1909-2018
  3. Recall initiated FDA recalls Z-1570-2022
  4. Recall initiated FDA recalls Z-1002-2024
  5. Recall initiated FDA recalls Z-1001-2024
  6. Recall initiated FDA recalls Z-3084-2024
  7. Recall initiated FDA recalls Z-3082-2024
  8. Recall initiated FDA recalls Z-3083-2024
  9. Recall initiated FDA recalls Z-3085-2024
  10. Recall initiated FDA recalls Z-2262-2026

7 earlier events are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Exactamix
Generic name
Compounding transfer set
Model / Ref / Catalog
H938174
Primary DI / UDI-DI
00085412475790
510(k) Number
FDA product code
NEP, LHI
GMDN term
Compounding transfer set
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution

Related devices

Category: Compounding transfer set

Cleared under the same submission (K002705)

and 8 more cleared under K002705

Similar devices

Other devices filed under FDA product code LHI.

Other devices from Baxter Healthcare Corp

See all devices from Baxter Healthcare Corp →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)