Class 1 Device Recall CareFusion, SnowdenPencer, DiamondFlex

• Date Initiated by Firm: July 01, 2016
• Date Posted: July 22, 2016
• Recall Status: Terminated on March 29, 2017
• Recall Number: Z-2212-2016
• Recall Event ID: 74465
• 510(K)Number: K092684
• Product Classification: Laparoscope, general & plastic surgery - Product Code GCJ
• Product: DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.
• Code Information: Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16
• Recalling Firm/ Manufacturer: Carefusion 2200 Inc; 75 N Fairway Dr; Vernon Hills IL 60061-1845
• For Additional Information Contact: Customer Advocacy; 800-323-9088
• Manufacturer Reason for Recall: BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure it has the potential to damages tissue or organs
• FDA Determined Cause: Material/Component Contamination
• Action: BD, sent an "URGENT: Medical Device/ Safety Alert/Recall Notification" letter dated 6/30/2016 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to return the affected units, along with the enclosed CUSTOMER RESPONSE FORM to: BD formerly CareFusion, 75 North Fairway Drive, Vernon Hills, Illinois, 60061 Attn: Customer Advocacy; to expedite the correction process and acknowledge receipt of the notification. The firm will issue a credit upon receipt of the returned affected product. For questions and support 1-800-323-9088 Prompt 3 or email: GMB-US-Complaint-Intake@carefusion.com.
• Quantity in Commerce: 10
• Distribution: Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.
• 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 = GCJ