SECURE 1000 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
The Metrix Company
Lot Codes / Batch Numbers
UDI/DI 00812496011602, Lot Numbers: 66055-A8336, 66055-A8483
Products Sold
UDI/DI 00812496011602, Lot Numbers: 66055-A8336, 66055-A8483
The Metrix Company is recalling SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plasti due to A limited number of IV bags have been found to leak during filling.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A limited number of IV bags have been found to leak during filling.
Recommended Action
Per FDA guidance
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: recall.coordinator@metrixco.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026