Z-2155-2019Class II

SenTec Membrane Changer Set (1 charger plus 1 insert) -

Name: Z-2155-2019 SenTec Membrane Changer Set (1 charger plus 1 insert) -
Creator: SenTec AG
Published: 2019-05-02
License: https://open.fda.gov/license/

Sentec AG / initiated 2019-05-02 / Terminated / root cause: manufacturing process

FDA source

SenTec AG began a recall of SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and... on 2019-05-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2155-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-02
Posted: 2019-08-05
Terminated: 2020-12-16
Recalling firm: Sentec AG
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.
Product code: LKD Monitor, Carbon-Dioxide, Cutaneous
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Lots: 180961, 181097, and 190053

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2155-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2152-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-05
Z-2153-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-05
Z-2154-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-05
Z-2155-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-05
Z-2156-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-05

Product code LKD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)