Z-1731-2024 Class II Ongoing
FDA device recall Z-1731-2024 was initiated by Covidien on Jan 9, 2024 and is designated Class II. Reason for recall: manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel The recall status is ongoing. Affected quantity: 1122 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2024
- Initiation Date
- Jan 9, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1122 units
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
Distribution Pattern
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
Code Information
Lot # 20221220 and 20230721; UDI: 10884521806436
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1731-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026