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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79209

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 04, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Draegar Medical Systems, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

INFINITY DUAL HEMO MCable Pod

Z-0942-2018
Recall number
Z-0942-2018
Initiated
October 04, 2017
Classification
Class II
Status
Terminated
Quantity
2,760

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Nationally