RecallDepth

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.

Company
The Metrix Company
Recall Initiated
October 9, 2024
Posted
November 8, 2024
Recall Number
Z-0335-2025
Quantity
2229 cases of 50 units
Firm Location
Dubuque, IA

Reason for Recall

A limited number of IV bags have been found to leak during filling.

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.

Lot / Code Info

UDI/DI 00812496011541, Lot Numbers: 66040-A8314, 66040-A8368, 66040-A8417, 66040-A8482

Root Cause

Under Investigation by firm

Action Taken

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

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