Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
Summary
The FDA issued a Class II for Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC by Covidien. Reason: manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel.
Details
Source
Device Recall
External ID
Z-1731-2024
Action Date
2024-05-08
Status
Ongoing
Category
device
Product Description
Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
Lot/Code Info: Lot # 20221220 and 20230721; UDI: 10884521806436
Quantity Affected: 1122 units
Reason for Recall
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-09
Company
Boulder, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 175 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Covidien has 33 FDA actions in our database, including 17 recalls and 16 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Covidien) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien have FDA actions?
Covidien has 33 FDA actions in our database, including 17 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1731-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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