CLASS II Device recall · Reported 3 Aug 2016 · FDA Enforcement Report

Container fill and transfer sets, automatic fill compatible recalled

The Metrix is recalling Container fill and transfer sets, automatic fill compatible, distributed in 21 states. The recall was initiated on 23 Jun 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique five character numeric or alphanumeric sequence. Affected product codes for this product: 58740, 58741, 58742, 58749, 58750, 58753, 58754

Quantity recalled18,366 cases

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-2261-2016
FDA event ID: 74043
Recalling firm: The Metrix, Dubuque, IA
Classification: Class II
Status: Terminated
Recall initiated: 23 Jun 2016
FDA classified: 22 Jul 2016
Reported: 3 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 Jun 2016	Recall initiated by company
22 Jul 2016	Classified by FDA	+29 days
3 Aug 2016	Published in enforcement report	+12 days

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

Reason for recall

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.

Product as listed by the FDA

Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL.

Where it was distributed

Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom

Alabama Arizona California Colorado Connecticut Florida Iowa Illinois Kansas Louisiana Massachusetts Maryland Minnesota North Carolina Ohio Pennsylvania Puerto Rico Tennessee Texas Utah

Questions about this recall

Why was it recalled?

Which lots are affected?

All lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique five character numeric or alphanumeric sequence. Affected product codes for this product: 58740, 58741, 58742, 58749, 58750, 58753, 58754

Where was it sold?

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

Other products in this recall event

7 other products · FDA event 74043

This product is part of a recall event; the main page for the event is AUTOCOMP6 XPS High Speed Compounder recalled by The Metrix.

Reported	Class	Recall	Company	Reason	Where
3 Aug 2016	CLASS II	AUTOCOMP6 XPS High Speed Compounder recalled by The Metrix	The Metrix	Other	21 states
3 Aug 2016	CLASS II	AUTOCOMP6 High Speed Compounder recalled by The Metrix	The Metrix	Other	21 states
3 Aug 2016	CLASS II	AUTOCOMP6 XP High Speed Compounder recalled by The Metrix	The Metrix	Other	21 states
3 Aug 2016	CLASS II	Container fill and transfer sets recalled by The Metrix	The Metrix	Other	21 states
3 Aug 2016	CLASS II	Dual Chamber Container fill with gravity/attached transfer sets recalled	The Metrix	Other	21 states
3 Aug 2016	CLASS II	Container fill and transfer sets recalled by The Metrix	The Metrix	Other	21 states
3 Aug 2016	CLASS II	Dual Chamber Container fill and transfer sets recalled by The Metrix	The Metrix	Other	21 states

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20 Nov 2024Device	CLASS II	Vygon Empty Eva Container With 2 Ports recalled by The Metrix	The Metrix	Packaging Defects	Nationwide
20 Nov 2024Device	CLASS II	Secure Empty Eva Container With 2 Ports (Bulk Packed) recalled	The Metrix	Packaging Defects	Nationwide

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