Home / Recalls / Physio-Control, Inc. / Z-0187-2018

Z-0187-2018 Class I Terminated

Recalled by Physio-Control, Inc. — Redmond, WA

FDA device recall Z-0187-2018 was initiated by Physio-Control, Inc. on October 27, 2017 and is designated Class I. Reason for recall: The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols. The recall status is terminated (terminated June 12, 2019). Affected quantity: 14,219 units in total.

Recall Details

Product Type
Devices
Report Date
December 20, 2017
Initiation Date
October 27, 2017
Termination Date
June 12, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14,219 units in total

Product Description

LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.

Reason for Recall

The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.

Distribution Pattern

Worldwide distribution: US (nationwide) including Puerto Rico and Guam and countries of: Canada, Austria, Belgium, Czech Republic; Denmark, Finland, France, French Polynesia, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Australia, China, Hong Kong, Japan, Argentina, Mexico, Norway, Panama, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, and New Zealand.

Code Information

45932237, 46042286, 45979590, 46050960, 45979954, 46052545, 46007867, 46061770, 46023185, 46063054, 46023823, 46078012,

Other recalls by Physio-Control, Inc.

  • Z-2065-2026 Class II — LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-0 (April 13, 2026)
  • Z-1544-2026 Class II — PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Num (January 21, 2026)
  • Z-2499-2025 Class II — LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 88 (July 22, 2025)
  • Z-2497-2025 Class II — LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / (July 22, 2025)
  • Z-2498-2025 Class II — LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 (July 22, 2025)
  • Z-1232-2025 Class II — LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in c (February 3, 2025)
  • Z-1102-2025 Class II — LIFEPAK 35 ECG cable REF 11111-000041 (January 21, 2025)
  • Z-1184-2025 Class II — LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, a (January 21, 2025)
  • Z-0230-2025 Class II — LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 9957 (August 30, 2024)
  • Z-0142-2025 Class II — STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEF (August 9, 2024)

FDA data resources