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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."
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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