FDAClass IIFebruary 12, 2020

Centurion- Driveline System Kit TRIDM250 OUTPATIENT recall: Sterility Concern

Centurion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM

Why was Centurion- Driveline System Kit TRIDM250 OUTPATIENT recalled?

Incomplete seals on the sterile package may compromise the sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM 2019012890

Product
Centurion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM
Recalling firm
Centurion Medical Products Corporation
Quantity
100
Distribution
Nationwide Foreign: GHANA
Recall date
February 12, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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