Class 2 Device Recall Vitrex

• Date Initiated by Firm: May 08, 2008
• Date Posted: August 14, 2008
• Recall Status: Terminated on January 22, 2010
• Recall Number: Z-2152-2008
• Recall Event ID: 48435
• Product Classification: blood gas capillary tubes - Product Code GIO
• Product: Vitrex Blood Gas Capillary Tubes, MC0024, REF 189301, 250 pcs, 1,45 x 1,85 x 125 mm app. 200l, Heparinized: 6 IU Na & 9 IU Li/100 l,
• Code Information: Part #MC0024, Lot #1112254
• Recalling Firm/ Manufacturer: Opti Medical Systems Inc; 235 Hembree Park Dr Ste 200; Roswell GA 300765700
• For Additional Information Contact: Len Owens; 770-510-4444 Ext. 573
• Manufacturer Reason for Recall: This lot of Heparinized Capillary Tubes contain contaminated lithium heparin.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Opti Medical sent a Recall Notice, dated May 8, 2008 to all consignees. Consignees were notified via email on/about May 5th thru 7th , 2008. They were instructed to discontinue use of the affected lot and to immediately return all remaining product to OPTI Medical for replacement.
• Quantity in Commerce: 31750 tubes
• Distribution: Worldwide Distribution: USA, Puerto Rico, Austria, China, Chile, Cyprus, Great Britain, Japan, Netherlands, and Senegal
• 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.