Z-0331-2025Class II
VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic...
The Metrix Company / initiated 2024-10-09 / Open, Classified
The Metrix Company began a recall of 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)... on . FDA classified it as Class II and gives the reason as "A limited number of IV bags have been found to leak during filling". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-0331-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- The Metrix Company
- Product
- 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.
- Product code
- KPE Container, I.V.
- Reason for recall
- A limited number of IV bags have been found to leak during filling.
- FDA root cause
- Under Investigation by firm
- Action
- The Metrix Company issued an URGENT: NOTICE OFMEDICAL DEVICE RECALL notice to it consignees on 10/09/2024 via email. The notice explained the issue and requested destruction of all affected product. Distributors were directed to notify their customers. For questions, contact: Demitrianna Soppe, Regulatory Affairs Specialist, The Metrix Company, 4400 Chavenelle Road, Dubuque, IA 52002; Telephone: 563-556-8800; E-mail: [email protected]
- Quantity in commerce
- 384 cases of 50 units
- 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.
- Product codes and lots
- UDI/DI 00812496011022, Lot Numbers: 62045-A8339, 62045-A8376, 62045-A8467
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0330-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0331-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0332-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0333-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0334-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0335-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0336-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0337-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0338-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0339-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0340-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0341-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0342-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0343-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0344-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0345-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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