FDAClass IIMarch 21, 2018

Infinity Dual Hemo Mcable Pod recall

INFINITY DUAL HEMO MCable Pod

Why was Infinity Dual Hemo Mcable Pod recalled?

Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value of invasive blood pressure.

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?

Have the affected revision indexes: 15 or 16 (found on the product label)

Product
INFINITY DUAL HEMO MCable Pod
Recalling firm
Draegar Medical Systems, Inc.
Quantity
2,760
Distribution
Nationally
Recall date
March 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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