Recall Z-0336-2025 ยท KPE Container, I.V.
The Metrix Company
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.
| Date | Nov 8, 2024 (initiated Oct 9, 2024) |
| Status | Open, Classified |
| Reason | A limited number of IV bags have been found to leak during filling. |
| 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: recall.coordinator@metrixco.com |
| Quantity | 2549 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030888 | EVA EMPTY SOLUTION CONTAINER Metrix Co., Apr 2, 2003 |