Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check Valve, Catalog number AVA 500 MPAT, Material number 3018231.
This recall has been terminated (originally issued March 23, 2010).
- Company
- Medrad Inc
- Recall Initiated
- January 6, 2010
- Posted
- March 23, 2010
- Terminated
- April 8, 2010
- Recall Number
- Z-1199-2010
- Quantity
- 2625 pieces
- Firm Location
- Indianola, PA
- Official Source
- View on FDA website ↗
Reason for Recall
The product may be defective resulting in a reduction of the saline delivery rate and inadequate air purging.
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.
Lot / Code Info
Lot numbers 820007 and 820008
Root Cause
Nonconforming Material/Component
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.