Recall Z-1199-2010 ยท DXT Injector And Syringe, Angiographic
Medrad Inc
Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check Valve, Catalog number AVA 500 MPAT, Material number 3018231.
| Date | Mar 23, 2010 (initiated Jan 6, 2010) |
| Status | Terminated |
| Reason | The product may be defective resulting in a reduction of the saline delivery rate and inadequate air purging. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued an Urgent Medical Device Recall letter dated 1/6/10 to all customers that received the affected lots. The customers were instructed to determine whether or not they had the affected product lots. Customers are to discontinue use and contact MEDRAD Customer Support or their MIP Rep to make arrangements for return of the recalled product. Any affected product returned will be replaced at no charge to the customer. Customers are also to complete and sign the attached form and fax it back to the firm. Questions concerning this recall are to be directed to Deb Easler, |
| Quantity | 2625 pieces |
| Distribution | Worldwide Distribution -- USA, including stated of AL, AZ, CA, DC, FL, GA, IL, KS, MD, MO, NM, NY, OH,OK, PA, TN, TX, and WI. and countries of Belgium, Germany, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050456 | MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM Medrad, Inc., Jun 17, 2005 |