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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Monitor, Carbon Dioxide and Oxygen, System see related information
Date Initiated by Firm May 02, 2019
Create Date August 05, 2019
Recall Status1 Terminated 3 on December 16, 2020
Recall Number Z-2152-2019
Recall Event ID 83115
510(K)Number K041548  K101690  K151329  
Product Classification Monitor, carbon-dioxide, cutaneous - Product Code LKD
Product SenTec Membrane Changer (reloadable) [9 pcs] - 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: 180763, 180834, 180872, 180874, 180876, 180970, 180993, 181011, 181016, 181031, 181034, 181045, 181072, 181087, 181103, 181141, 190080, 190141, 190165, 190203, 190210, and 190264
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 2		 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 198 pcs.
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 and Original Applicant = SENTEC AG
510(K)s with Product Code = LKD and Original Applicant = SENTEC INC.
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