Class 2 Device Recall Medrad Avanta Multipatient Disposable Sets

• Date Initiated by Firm: September 20, 2005
• Date Posted: October 21, 2005
• Recall Status: Terminated on January 20, 2006
• Recall Number: Z-0083-06
• Recall Event ID: 33689
• 510(K)Number: K050456
• Product Classification: Set, I.V. Fluid Transfer - Product Code LHI
• Product: Medrad Avanta Multi-patient Disposable Sets. Catalog number AVA 500 MPAT
• Code Information: Lot numbers 50627, 50628, 51069, 51070, 51071, and 51747
• Recalling Firm/ Manufacturer: Medrad Inc; 1 Medrad Dr; Indianola PA 15051-9759
• For Additional Information Contact: Laurence R. Kopyta; 412-767-2400 Ext. 3621
• Manufacturer Reason for Recall: stress crack on the stopcock
• FDA Determined Cause: Other
• Action: The recalling firm issued letters dated 9/20/05 to the hospitals and sales representative informing them of the problem and the need to return the product.
• Quantity in Commerce: 850 units
• Distribution: The products were shipped to medical facilities in CA, CO, DE, FL, IL, MA, NC, OH, PA, and VA. The products were also shipped to sales representatives in CA, CO, FL, MA, MN, MO, OK, PA, SC, and WI. The products were sent to the recalling firm''s distributors in the Netherlands, Denmark, France, and Italy.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LHI and Original Applicant = MEDRAD, INC.