Draegar Medical Systems, Inc.: INFINITY DUAL HEMO MCable Pod

Recall number

Z-0942-2018

Recalling firm

Draegar Medical Systems, Inc.

Product

INFINITY DUAL HEMO MCable Pod

Status

Terminated

Initiated

2017-10-04

Posted

not on file

Terminated

2018-06-15

Reason

Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Drger 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.

Root cause

Nonconforming Material/Component

Action

In September of 2017 an Urgent medical Device Recall letter was issued to customers informing them of the recall and to request that inventory be checked to see if the product subject in the recall is on the premises. To do this, the customer will check the label for the revision index number which is located on the upper middle portion of label. RI number 15 and 16 are included in the recall. No other numbers are subject to recall. Affected product will receive a sleeve from the company to correct the issue. Questions or concerns can be directed to 1-800-437-2437 (Press 1, then press 32349) or contact Customer Care at 1-800-437-2437 (Press 4, then press 4 again)

Quantity

2,760

Distribution

Nationally

Lot, serial or model codes

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

510(k) numbers

["K113798"]

PMA numbers

not on file

Product code

MHX

Firm FEI

3005783425

Firm city

Andover

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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