Class 2 Device Recall smiths medical medex CBSS5ML, Double set

• Date Initiated by Firm: March 10, 2020
• Create Date: October 13, 2021
• Recall Status: Terminated on September 22, 2023
• Recall Number: Z-0103-2022
• Recall Event ID: 88667
• Product Classification: Pacemaker, cardiac, external transcutaneous (non-invasive) - Product Code DRO
• Product: smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
• Code Information: All codes
• Recalling Firm/ Manufacturer: Smiths Medical ASD Inc.; 6000 Nathan Ln N; Minneapolis MN 55442-1690
• For Additional Information Contact: Dave Halverson; 763-383-3310
• Manufacturer Reason for Recall: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
• FDA Determined Cause: Component design/selection
• Action: The firm initiated the recall by letter during the week of 03/10/2020. The notices requested the direct consignee notify their customers and collect the responses. The firm is seeking return of the products.
• Quantity in Commerce: 3620 units
• Distribution: Austria, France, Germany, Great Britain, and Saudi Arabia
• 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.