Medtronic Invos Infant Sensor Cables recalled for manufacturing defects
Covidien is recalling 1,122 Medtronic Invos Reusable Infant Sensor Adapter Cables due to manufacturing defects in connectors. The defects may cause error codes or non-functioning monitoring channels.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device used for infant vital sign monitoring. Manufacturing defects could result in loss of critical patient monitoring data, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Covidien is recalling 1,122 Medtronic Invos Reusable Infant Sensor Adapter Cables for the PM7100 patient monitoring system. The recalled product is identified by Reference Number PMAC71RIC with Lot Numbers 20221220 and 20230721.
Manufacturing defects in the sensor cable connectors may cause error codes or non-functioning monitoring channels. These defects could prevent the patient monitoring system from displaying vital sign information.
The affected cables were distributed to healthcare facilities across 24 U.S. states and more than 30 countries worldwide.
The recalled product
- Product
- Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
- Manufacturer
- Covidien
- Hazard
- device-malfunction
- signal-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 20221220 and 20230721
- UDI: 10884521806436
Distribution
Distributed in 25 states:
- 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
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