SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic inten
FDA device recall Z-0336-2025 · posted 2024-11-08 · Open, Classified
Recall details
- Recalling firm
- The Metrix Company
- Reason for recall
- A limited number of IV bags have been found to leak during filling.
- 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
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- KPE
- Quantity affected
- 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.
- Date initiated
- 2024-10-09
- Date posted
- 2024-11-08
- Location
- Dubuque, IA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVA EMPTY SOLUTION CONTAINER (K030888) | Metrix Co. | 2003-04-02 |