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INVOS recallZ-1731-2024 · Covidien · initiated Jan 9, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Covidien or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel

FDA root cause category: Process design

What the company is doing

On January 9, 2024 Medtronic (parent company of Covidien) issued a Urgent Medical Device Recall notification via UPS. Medtronic asked consignees to take the following action: 1. Quarantine and stop using all product from the affected lots of INVOS" Reusable Sensor Cables PMAC71RSC and PMAC71RIC. " See attachment A for guidance on how to identify affected devices via cable box packaging or cable hang tag. 2. Complete and return Customer Confirmation Form. Complete and return the enclosed Customer Confirmation Form even if you do not have any affected lots remaining. 3. Reach out to Medtronic to obtain RGA # /Returned Goods Authorization number. " Your Medtronic Representative / Medtronic Customer Service at [email protected] can assist in initiating product return as necessary. 4. Return all product from the affected lots in your possession to Medtronic as described on the Customer Confirmation Form. 5. Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product from the specified lots has been transferred or distributed.

Recall details

Recall number
Z-1731-2024
Status
Open, Classified
Initiated by the company
Jan 9, 2024
Posted by the FDA
Apr 30, 2024
Recalling firm
Covidien
Quantity
1122 units
Product code
MUD
FDA submissions
K211561
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

Product description

Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC

Code information (models, lots, serial numbers)

Lot # 20221220 and 20230721; UDI: 10884521806436

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

9 devices cleared under K211561 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93883).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page