Class 2 Device Recall Monitor, Carbon Dioxide and Oxygen, System

• Date Initiated by Firm: May 02, 2019
• Create Date: August 05, 2019
• Recall Status: Terminated on December 16, 2020
• Recall Number: Z-2155-2019
• Recall Event ID: 83115
• 510(K)Number: K041548 K101690 K151329
• Product Classification: Monitor, carbon-dioxide, cutaneous - Product Code LKD
• Product: SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
• Code Information: Lots: 180961, 181097, and 190053
• Recalling Firm/ Manufacturer: SenTec AG; Ringstrasse 39; Therwil Switzerland
• Manufacturer Reason for Recall: There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
• FDA Determined Cause: Process control
• Action: On May 2, 2019, the firm sent Guidance for SenTec Distributors to their distributors advising them of the issue, requesting them to check their stock and notify their end users via a voluntarily initiated field correction action associated with Membrane Changers and their Inserts which was enclosed with the "recall" letters. The distributors were to report back to SenTec via email.
• Quantity in Commerce: 3 sets
• Distribution: Worldwide distribution - US Nationwide in the state of Missouri and countries of Argentina, Australia, Austria, Belgium, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Ecuador, Europe, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Israel, Italy, Kuwait, Malaysia, Finland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, United Arab Emirates and United Kingdom.
• 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 = LKD; 510(K)s with Product Code = LKD