Z-0007-2020Class II

ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter -

Name: Z-0007-2020 ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter -
Creator: The Metrix Company
Published: 2018-09-21
License: https://open.fda.gov/license/

The Metrix Company / initiated 2018-09-21 / Open, Classified / root cause: manufacturing process

FDA source

The Metrix Company began a recall of ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture... on 2018-09-21. FDA classified it as Class II and gives the reason as "Potential for leaking product". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0007-2020
Classification: Class II
Status: Open, Classified
Initiated: 2018-09-21
Posted: 2019-10-01
Recalling firm: The Metrix Company
Product: ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Product code: KPE Container, I.V.
Reason for recall: Potential for leaking product
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The Metrix Company notified the direct account (distributors) by telephone on 09/21/2019. The firm asked if the consignees received any complaints of leaking during the divider rod removal and return of any of the lot. The firm expanded the recall and disseminated the notices by email and telephone on 08/2/30/2019. Press was issued on 09/09/2019.
Quantity in commerce: 175392 bags
Distribution: US Nationwide distribution including the states of PA, MA, IL CA.
Product codes and lots: Lot Numbers: H938901 63615-A1768, H938901 63615-A1770, H938901 63615-A1772, H938901 63615-A2648, H938901 63615-A2650, H938901 63615-A2652, H938901 63615-A2653, H938901 63615-A2654, H938901 63615-A2656, H938901 63615-A2658, H938901 63615-A2660, H938901 63615-A2662, H938901 63615-A3951, H938901 63615- A3953, H938901 63615-A3955, H938901 63615-A3958, H938901 63615-A3960, H938901 63615-A3962, H938901 63615-A3964, H938901 63615-A3966, H938901 63615-A3967, H938901 63615-A5337, H938901 63615-A5339, H938901 63615-A5341, H938901 63615-A5343, H938901 63615-A5345, H938901 63615-A5347, H938901 63615-A5349

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0007-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0001-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-10-09	2019-10-01
Z-0002-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-10-09	2019-10-01
Z-0003-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-10-09	2019-10-01
Z-0004-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-10-09	2019-10-01
Z-0005-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-10-09	2019-10-01
Z-0006-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-10-09	2019-10-01
Z-0007-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-10-09	2019-10-01
Z-0008-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-10-09	2019-10-01

Product code KPE

K960581Class IISecure Eva Dual Chamber Mixing BagSecure Medical Products, Inc. / cleared 1996-04-30

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)