FDA Enforcement
Class II
Ongoing
Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
Recall: Z-1731-2024
·
Reported May 8, 2024
Enforcement
- Recall Number
- Z-1731-2024
- Event ID
- 93883
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Covidien
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 8, 2024
- Initiation Date
- January 9, 2024
- Classification Date
- April 30, 2024
- Address
- 6135 Gunbarrel Ave, Boulder, CO, 80301-3214, United States
Description
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
Code Info
Lot # 20221220 and 20230721; UDI: 10884521806436
Distribution
US: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI OUS: Australia Austria Belgium Canary Islands Chile Czech Republic Denmark Finland France Germany Guatemala Indonesia Ireland Italy Japan Korea, Republic Of Kuwait Lithuania Mayotte New Zealand Nicaragua Poland Portugal Romania Slovakia Spain Sweden Switzerland Taiwan United Kingdom
Quantity
1122 units