medical HIGH RISK Updated 2017-12-20

Physio-Control, Inc. recalls LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, M

See all recalls from Physio-Control, Inc. →

Recalled Product

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.

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 45932237, 46042286, 45979590, 46050960, 45979954, 46052545, 46007867, 46061770, 46023185, 46063054, 46023823, 46078012,

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for LIFEPAK(R) Electrode Starter Kits, →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

Related medical Recalls

Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-0027/16;

2026-03-18 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-0027/12;

2026-03-18 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-8521/11;

2026-03-18 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Instrumentation Laboratory recalls GEM Premier 5000 PAK; Part No. 00055407504.

2026-03-18 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.