Device recall: VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to…
Class II FDA enforcement event 95499. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
A limited number of IV bags have been found to leak during filling.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
The Metrix Company started this device recall on 9 Oct 2024. The firm address in the FDA record is in Dubuque, IA. FDA put the recall in Class II. FDA event 95499 has 16 product records. The first FDA enforcement report date is 20 Nov 2024. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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.
Recalling firm
The Metrix Company, Dubuque, IA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
16 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0330-2025 | VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | 288 cases of 50 units | Class II | Ongoing | 20 Nov 2024 |
| Z-0331-2025 | VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | 384 cases of 50 units | Class II | Ongoing | 20 Nov 2024 |
| Z-0332-2025 | CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | 1920 cases of 50 units | Class II | Ongoing | 20 Nov 2024 |
| Z-0333-2025 | CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | 3456 cases of 50 units | Class II | Ongoing | 20 Nov 2024 |
| Z-0334-2025 | CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | 1440 cases of 50 units | Class II | Ongoing | 20 Nov 2024 |
| Z-0335-2025 | SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | 2229 cases of 50 units | Class II | Ongoing | 20 Nov 2024 |
| Z-0336-2025 | SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | 2549 cases of 50 units | Class II | Ongoing | 20 Nov 2024 |
| Z-0337-2025 | SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | 1013 cases of 50 units | Class II | Ongoing | 20 Nov 2024 |
| Z-0338-2025 | SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | 83 cases of 50 units | Class II | Ongoing | 20 Nov 2024 |
| Z-0339-2025 | SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | 2921 cases of 50 units | Class II | Ongoing | 20 Nov 2024 |
| Z-0340-2025 | SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | 1020 cases of 50 units | Class II | Ongoing | 20 Nov 2024 |
| Z-0341-2025 | 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. | 277 cases of 50 units | Class II | Ongoing | 20 Nov 2024 |
| Z-0342-2025 | Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | 768 units | Class II | Ongoing | 20 Nov 2024 |
| Z-0343-2025 | Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | 1056 cases of 50 units | Class II | Ongoing | 20 Nov 2024 |
| Z-0344-2025 | Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | 864 cases of 50 units | Class II | Ongoing | 20 Nov 2024 |
| Z-0345-2025 | Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | 96 cases of 50 units | Class II | Ongoing | 20 Nov 2024 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 16Median of the firm: 8
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 21 Sep 2018 | SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an in | Device | Class II | 8 |
| 13 Sep 2017 | SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R, | Device | Class II | 1 |
| 23 Jun 2016 | AUTOCOMP6 XPS High Speed Compounder REF 58810 | Device | Class II | 8 |
Official channels
- FDA enforcement report Z-0330-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 95499. https://recallregister.com/fda/ii/95499/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
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 quantity of product is in FDA event 95499?
- The event has 16 product records. The first record gives this quantity:
288 cases of 50 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.