CLASS II ONGOING Device recall · Reported 9 Oct 2019 · FDA Enforcement Report

ExactaMix, Model: H938901, Empty EVA Dual Chamber Container recalled

The Metrix is recalling ExactaMix, Model: H938901, Empty EVA Dual Chamber Container With, distributed nationwide in the US. The recall was initiated on 21 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Quantity recalled175392 bags

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0007-2020
FDA event ID: 83509
Recalling firm: The Metrix, Dubuque, IA
Classification: Class II
Status: Ongoing
Recall initiated: 21 Sep 2018
FDA classified: 1 Oct 2019
Reported: 9 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

21 Sep 2018	Recall initiated by company
1 Oct 2019	Classified by FDA	+375 days
9 Oct 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for leaking product

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution including the states of PA, MA, IL CA.

Nationwide California Illinois Massachusetts Pennsylvania

Questions about this recall

Is ExactaMix, Model: H938901, Empty EVA Dual Chamber Container With recalled?

Yes. The Metrix recalled ExactaMix, Model: H938901, Empty EVA Dual Chamber Container With on 21 Sep 2018. The recall is Class II and its status is Ongoing. Recall number Z-0007-2020.

Why was it recalled?

Potential for leaking product

Which lots are affected?

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

Where was it sold?

US Nationwide distribution including the states of PA, MA, IL CA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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