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Z-2153-2019 Class II Terminated

Recalled by SenTec AG — Therwil, N/A

FDA device recall Z-2153-2019 was initiated by SenTec AG on May 2, 2019 and is designated Class II. 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. The recall status is terminated (terminated December 16, 2020). Affected quantity: 22 pcs.

Recall Details

Product Type: Devices
Report Date: August 14, 2019
Initiation Date: May 2, 2019
Termination Date: December 16, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 22 pcs

Product Description

SenTec Standard Starter Set with and without Service Gas (2 changers each) - 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.

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.

Distribution Pattern

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.

Code Information

Standard Starter Set Lots: 180932, 180959, 181019, 181082, 190005, 190041, 190093, 190221, and 190282. Standard Starter Set (without Service Gas) Lots:180972 and 190078

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Z-0088-2017 Class II — SDMS (SenTec Digital Monitoring System) (September 15, 2016)
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