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U.S. Department of Health and Human Services

Class 1 Device Recall CareFusion, SnowdenPencer, DiamondFlex

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  Class 1 Device Recall CareFusion, SnowdenPencer, DiamondFlex see related information
Date Initiated by Firm July 01, 2016
Date Posted July 22, 2016
Recall Status1 Terminated 3 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/
Carefusion 2200 Inc
75 N Fairway Dr
Vernon Hills IL 60061-1845
For Additional Information Contact Customer Advocacy
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 2
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 and Original Applicant = CARDINAL HEALTH, INC.