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Exactamix H938905

by Baxter Healthcare Corp

Exactamix H938905 is a Class II device made by Baxter Healthcare Corp, cleared under FDA 510(k) K960581 on 30 Apr 1996 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00085412477473), active as of 23 Oct 2026. 8 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) K960581

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 Number00085412477473 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK960581 Date30 Apr 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K960581 decided 30 Apr 1996 Active
  • FDA GUDID UDI-DI 00085412477473 listed 23 Sep 2016 Listed

Recalls

9 recalls · 8 ongoing · FDA

  • 8 recalls, same reason

    • Ongoing Z-0002-2020 FDA Class II initiated 21 Sep 2018
    • Ongoing Z-0008-2020 FDA Class II initiated 21 Sep 2018
    • Ongoing Z-0005-2020 FDA Class II initiated 21 Sep 2018
    • Ongoing Z-0001-2020 FDA Class II initiated 21 Sep 2018
    • Ongoing Z-0007-2020 FDA Class II initiated 21 Sep 2018
    • Ongoing Z-0003-2020 FDA Class II initiated 21 Sep 2018
    • Ongoing Z-0004-2020 FDA Class II initiated 21 Sep 2018
    • Ongoing Z-0006-2020 FDA Class II initiated 21 Sep 2018

    Potential for leaking product

    • Terminated Z-2263-2016 FDA Class II initiated 23 Jun 2016 on shared 510(k) K960581

    An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

11 dated events

  1. Recall initiated FDA recalls Z-2263-2016
  2. Listed FDA GUDID 00085412477473
  3. Recall initiated FDA recalls Z-0002-2020
  4. Recall initiated FDA recalls Z-0008-2020
  5. Recall initiated FDA recalls Z-0005-2020
  6. Recall initiated FDA recalls Z-0001-2020
  7. Recall initiated FDA recalls Z-0007-2020
  8. Recall initiated FDA recalls Z-0003-2020
  9. Recall initiated FDA recalls Z-0004-2020
  10. Recall initiated FDA recalls Z-0006-2020

1 earlier event 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
Intravenous administration bag/bottle
Model / Ref / Catalog
H938905
Primary DI / UDI-DI
00085412477473
510(k) Number
FDA product code
KPE
GMDN term
Intravenous administration bag/bottle
Device class
Class II
Regulation number
880.5025
GUDID distribution status
In Commercial Distribution

Related devices

Category: Intravenous administration bag/bottle

Cleared under the same submission (K960581)

and 5 more cleared under K960581

Similar devices in this category

Other devices filed under Intravenous administration bag/bottle.

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)