Z-0364-2019Class II

EXACTAMIX Empty EVA Bags - 500 mL -

Name: Z-0364-2019 EXACTAMIX Empty EVA Bags - 500 mL -
Creator: Baxter Healthcare Corporation
Published: 2018-09-12
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2018-09-12 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an... on 2018-09-12. FDA classified it as Class II and gives the reason as "Potential ability to leak once used for compounding". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0364-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-12
Posted: 2018-11-02
Terminated: 2020-11-02
Recalling firm: Baxter Healthcare Corporation
Product: EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Product code: KPE Container, I.V.
Reason for recall: Potential ability to leak once used for compounding.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An Urgent Product Recall communication will be sent to affected customers via U.S.P.S., first class mail. Baxter is asking customers to: 1. Locate and remove all affected product from your facility. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. 3. Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or email. Notification Effectiveness: 100%. The non-responding customers will be contacted via telephone. Expansion on 02/19/2019, Baxter notified customers (and additional customers) of recall and additional lots included.
Quantity in commerce: 110,134 units
Distribution: Worldwide distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. Countries of Canada, Australia, New Zealand, China, Hong Kong, Brazil, Chile, and Uruguay.
Product codes and lots: Product Code H938738 Lot #'s: 60055343, 60080326, 60081686, 60084628, 60084630, 60091155, 60098887, and 60103959. **Update expansion on 02/19/2019 with lot numbers: 60066390, 60072129, 60084627, 60089799, 60104861, 60108274, 60109594, 60126011.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0364-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0363-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-11-01
Z-0364-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-11-01
Z-0365-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-11-01
Z-0366-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-11-01
Z-0367-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-11-01

Product code KPE

K900585Class IITubing Sets for Baxa Exacta-Med Pharmacy PumpBaxa Corp., Sub. of Cook Group, Inc. / cleared 1990-04-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)