FDA Device recall Z-3109-2017
Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion
- FDA Device
- Class I
- terminated
- Published 2017-09-20
On 2017-09-20 the FDA classified a Class I recall of Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion by Leonhard Lang Medizintechnik, citing certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a si….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3109-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-08-08 |
| Published | 2017-09-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Leonhard Lang Medizintechnik |
| Distribution | FL, TX |
Product
Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external defibrillators
Reason
Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.
Identifiers
| code_info | Model Number DF59N (lot numbers 41219-0778, 50403-0772, 41029-0770), DF59NC (lot numbers 50211-0974, 50402-0974, 40806-…Model Number DF59N (lot numbers 41219-0778, 50403-0772, 41029-0770), DF59NC (lot numbers 50211-0974, 50402-0974, 40806-0972, 41203-0973, 50116-0975, 50527-0974). Expiration date 09/2017 to 05/31/2018. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3109-2017%22
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