Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for ext
FDA device recall Z-3109-2017 · posted 2017-09-12 · Terminated
Recall details
- Recalling firm
- Leonhard Lang Medizintechnik GmbH
- Reason for recall
- 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.
- Action taken
- On approximately 08/08/2017, customers were notified via email of the recall. Instructions included to ensure all users and anyone concerned are aware of the recall, coordinate the replacement of affected product, once replacement electrodes are received document destruction of affected product on-site, and notify customers if the product had been further distributed.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 8,249 units total
- Distribution
- Worldwide distribution. US distribution in the states of : FL & TX. Austria, China, France, Germany, Greece, Hungary, India, Italy, Panama, Philippines, Poland, Saudi Arabia, Serbia, South Africa, Sou
- Date initiated
- 2017-08-08
- Date posted
- 2017-09-12
- Date terminated
- 2020-06-09
- Location
- Innsbruck, Austria
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Skintact, various other tradenames (K142803) | Leonhard Lang GmbH | 2014-12-02 |