Recall Z-1731-2024— Covidien

Name: FDA recall Z-1731-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-09

Class II · Ongoing

Class II FDA medical device recall by Covidien, initiated 2024-01-09. It names one FDA 510(k) clearance: K211561. Product: Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC. Reason: manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel.

Recalling firm: Covidien
Classification: Class II
Status: Ongoing
Initiated: 2024-01-09
Firm location: Boulder, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K211561 — INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)Covidien, LLC·cleared 2021-12-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC

Reason for recall

manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel

Data sourced from openFDA. This site is unofficial and independent of the FDA.