Class 2 Device Recall Manometer Tray Sterile

• Date Initiated by Firm: February 23, 2017
• Create Date: April 18, 2018
• Recall Status: Terminated on July 09, 2019
• Recall Number: Z-1421-2018
• Recall Event ID: 76620
• Product Classification: Manometer, blood-pressure, venous - Product Code KRK
• Product: Manometer, 550 ml three-Way Stopcock; STERILE
• Code Information: Product Code: 4330 Lot Code: 0000837810; 0000840335; 0000842213; 0000848531; 0000851181; 0000853962
• Recalling Firm/ Manufacturer: Carefusion 2200 Inc; 75 N Fairway Dr; Vernon Hills IL 60061-1845
• For Additional Information Contact: Christine Cox, RN; 847-362-9439
• Manufacturer Reason for Recall: The integrity of the sterile packaging is potentially compromised.
• FDA Determined Cause: Package design/selection
• Action: On 2/23/2017, firm notified customers of recall via mailed letter. The letter included a recall response form. Customers were directed to either return the affected product along with the response form or destroy it and return the response form, indicating the product had been destroyed. All affected product will be destroyed.
• Quantity in Commerce: 4,240 units
• Distribution: Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam
• 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.