Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check Valve, Catalog
FDA device recall Z-1199-2010 · posted 2010-03-23 · Terminated
Recall details
- Recalling firm
- Medrad Inc
- Reason for recall
- The product may be defective resulting in a reduction of the saline delivery rate and inadequate air purging.
- Action taken
- 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, Product Manager, at 412-767-2400.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 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.
- Date initiated
- 2010-01-06
- Date posted
- 2010-03-23
- Date terminated
- 2010-04-08
- Location
- Indianola, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM (K050456) | Medrad, Inc. | 2005-06-17 |