Physio-Control Recalls LIFEPAK Electrode Starter Kits Due to Labeling Errors
Physio-Control is recalling 14,219 LIFEPAK Electrode Starter Kits because the infant artwork shows incorrect pad placement and is missing required warning symbols.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, but the source text describes the defect as incorrect artwork and missing warning symbols without reporting any injuries, illnesses, or deaths. This aligns with the rubric for minor labeling errors or voluntary precautionary recalls where the hazard is theoretical.
Plain-English summary
Physio-Control, Inc. is recalling 14,219 units of LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009. These defibrillation electrodes are used with specific LIFEPAK AED and defibrillator models that have a pink connector.
The recall was initiated because the infant artwork on the product instructs incorrect pad placement. Additionally, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols. The affected units were distributed worldwide, including the United States (nationwide, Puerto Rico, and Guam) and numerous international locations.
Consumers should stop using the affected electrode starter kits and contact Physio-Control for further instructions. The recall number is Z-0187-2018.
The recalled product
- 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.
- Manufacturer
- Physio-Control, Inc.
- Affected units
- 14,219
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 45932237
- 46042286
- 45979590
- 46050960
- 45979954
- 46052545
- 46007867
- 46061770
- 46023185
- 46063054
- 46023823
- 46078012
Distribution
Part of a larger recall action
This product is one of 2 recalled by Physio-Control, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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