Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact Medical di
FDA device recall Z-1126-2017 · posted 2017-02-02 · Terminated
Recall details
- Recalling firm
- Medtronic Advanced Energy, LLC
- Reason for recall
- Product sterility compromised due to breach of sterile barrier
- Action taken
- Medtronic Advanced Energy notified customers by letter on December 27, 2016 via Next Day FEDEX. The communication advises users to immediately stop using the affected Intact Disposable Wands and to quarantine them until they can be returned to Medtronic. Medtronic Sales representatives will arrange for the return of all recalled product.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 10 units
- Distribution
- Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
- Date initiated
- 2016-12-28
- Date posted
- 2017-02-02
- Date terminated
- 2017-05-11
- Location
- Portsmouth, NH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EN BLOC BIOPSY SYSTEM (K003190) | Neothermia Corp. | 2001-06-11 |