Class 2 Device Recall Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape

• Date Initiated by Firm: July 28, 2017
• Create Date: August 21, 2017
• Recall Status: Terminated on December 26, 2017
• Recall Number: Z-3046-2017
• Recall Event ID: 77917
• Product Classification: Sudan iv - Product Code KKK
• Product: Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case
• Code Information: Lot number 17DAH349
• FEI Number: 3001236905
• Recalling Firm/ Manufacturer: Cardinal Health 200, LLC; 1500 S Waukegan Rd; Waukegan IL 60085-6728
• For Additional Information Contact: Customer Advocacy; 800-292-9332
• Manufacturer Reason for Recall: Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings.
• FDA Determined Cause: Packaging process control
• Action: Cardinal Health sent an Urgent: Product Recall letter dated July 28, 2017. Distributors are requested to notify their customers of the action. An acknowledgement form is included as part of the notification. Responses are tracked. All returned product will be quarantined. All inventory recovered from the field will be destroyed. For further questions, please call (800) 292-9332.
• Quantity in Commerce: 200 units
• Distribution: US Distribution to the states of : NC, UT, OR, NY,TX, GA, NJ and FL.
• 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.