CLASS II ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report
Secure Empty Eva Container With 2 Ports recalled by The Metrix
The Metrix is recalling Secure Empty Eva Container With 2 Ports, distributed nationwide in the US. The recall was initiated on 9 Oct 2024 and the FDA has classified it as Class II.
Check your package
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-0341-2025
- FDA event ID
- 95499
- Recalling firm
- The Metrix, Dubuque, IA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Oct 2024
- FDA classified
- 8 Nov 2024
- Reported
- 20 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 9 Oct 2024 | Recall initiated by company | |
| 8 Nov 2024 | Classified by FDA | +30 days |
| 20 Nov 2024 | 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
A limited number of IV bags have been found to leak during filling.
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
SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Where it was distributed
Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
Nationwide CaliforniaFloridaIllinoisMassachusettsMarylandMichiganOhioPennsylvaniaPuerto RicoTexasUtahWashington
Questions about this recall
Why was it recalled?
A limited number of IV bags have been found to leak during filling.
Which lots are affected?
UDI/DI 00812496011602, Lot Numbers: 66055-A8336, 66055-A8483
Where was it sold?
Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
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
15 other products · FDA event 95499This product is part of a recall event; the main page for the event is Secure Empty Eva Container With 2 Ports recalled by The Metrix.
More recalls from The Metrix
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Imed Products Imed EVA, 2-Ports recalled by The Metrix | The Metrix | Packaging Defects | Nationwide |
| Device | CLASS II | Secure Empty Eva Container With 2 Ports recalled by The Metrix | The Metrix | Packaging Defects | Nationwide |
| Device | CLASS II | Vygon Empty Eva Container With 2 Ports recalled by The Metrix | The Metrix | Packaging Defects | Nationwide |
| Device | CLASS II | Secure Empty Eva Container With 2 Ports (Bulk Packed) recalled | The Metrix | Packaging Defects | Nationwide |
| Device | CLASS II | Secure Empty Eva Container With 2 Ports (Bulk Packed) recalled | The Metrix | Packaging Defects | Nationwide |
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