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.
This recall is currently active, issued November 8, 2024. It was issued by The Metrix Company.
- Company
- The Metrix Company
- Recall Initiated
- October 9, 2024
- Posted
- November 8, 2024
- Recall Number
- Z-0342-2025
- Quantity
- 768 units
- Firm Location
- Dubuque, IA
- Official Source
- View on FDA website ↗
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 00812496011305, Lot Numbers: 68040-A8318, 68040-A8408, 68040-A8441, 68040-A8474
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