Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).
Reported: September 27, 2023 Initiated: July 25, 2023 #Z-2592-2023
Product Description
Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).
Reason for Recall
During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance.
Details
- Recalling Firm
- SenTec AG
- Units Affected
- REVISED 9/21/2023-15,065 packages
- Distribution
- US Nationwide distribution.
- Location
- Therwil
Frequently Asked Questions
What product was recalled? ▼
Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).. Recalled by SenTec AG. Units affected: REVISED 9/21/2023-15,065 packages.
Why was this product recalled? ▼
During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 27, 2023. Severity: Moderate. Recall number: Z-2592-2023.
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