Home / Recalls / Draegar Medical Systems, Inc. / Z-0942-2018

Z-0942-2018 Class II Terminated

Recalled by Draegar Medical Systems, Inc. — Andover, MA

FDA device recall Z-0942-2018 was initiated by Draegar Medical Systems, Inc. on October 4, 2017 and is designated Class II. 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 potent… The recall status is terminated (terminated June 15, 2018). Affected quantity: 2,760.

Recall Details

Product Type
Devices
Report Date
March 21, 2018
Initiation Date
October 4, 2017
Termination Date
June 15, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,760

Product Description

INFINITY DUAL HEMO MCable Pod

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.

Distribution Pattern

Nationally

Code Information

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

Other recalls by Draegar Medical Systems, Inc.

  • Z-1012-2022 Class II — Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For (March 4, 2022)
  • Z-1104-2021 Class II — Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for (December 23, 2020)
  • Z-0372-2020 Class II — Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, M (October 9, 2019)
  • Z-0258-2020 Class II — The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone In (September 13, 2019)
  • Z-0974-2019 Class II — Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta (February 8, 2019)
  • Z-0975-2019 Class II — Omega Systems These devices are intended to be used in the environment where (February 8, 2019)
  • Z-1813-2018 Class II — Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, (March 28, 2018)
  • Z-1382-2018 Class II — Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, (February 21, 2018)
  • Z-2734-2017 Class II — Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK3 (June 6, 2017)
  • Z-1772-2017 Class II — Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Ox (March 28, 2017)

FDA data resources