FDA recall Z-0183-2025

Product

medex TranStar Single ICP Set 1/EA, Product Code REF MX20897

Reason for recall

Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-09-24

Report date

2024-10-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0183-2025