FDAFDA · Food and drugs·Recall number Z-1731-2024
Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
Published May 8, 2024 · Recall initiated: January 9, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien
- Distributor
- 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
- Lot
- Lot # 20221220 and 20230721; UDI: 10884521806436
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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