The FDA announced on 2017-10-27 that Physio-Control, Inc. is recalling LIFEPAK(R) Electrode Starter Kits due to incorrect infant pad placement instructions and missing safety symbols. The agency classified the recall as Class I.
How to tell if you have it
- Brand: Physio-Control
- Product: LIFEPAK(R) Electrode Starter Kits
- Catalog #: 11101-000017
- MIN: #3202784-009
- Lot codes: 45932237, 46042286, 45979590, 46050960, 45979954, 46052545, 46007867, 46061770, 46023185, 46063054, 46023823, 46078012
- Quantity: 14,219 units
The hazard
According to the FDA, the infant artwork on the product instructs incorrect pad placement. The artwork is also missing the Type BF Patient connection and High Voltage Warning symbols.
Context
GovInfoNow's records show Physio-Control, Inc. has 17 other recalls on record since 2017-12-04. Recent brand recalls include LIFEPAK 15 Defibrillators (2026-04-13), Infant/Child Defibrillator Electrodes (2026-01-21), and LIFEPAK 1000 Defibrillator (2025-07-22). Other recent recalls of similar products include Medline Medical Procedure Kits (2026-05-04), Medline Medical Kits (2026-03-16), and Medline Basic Nerve Block Tray (2026-01-07).