Recall Z-1128-2017
Medtronic Advanced Energy, LLC · initiated December 28, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Codes / lots: All lot codes
Reason for recall
Product sterility compromised due to breach of sterile barrier
FDA-determined cause: Package design/selection
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.
Details
- Recall number
- Z-1128-2017
- Initiated
- December 28, 2016
- Posted by FDA
- February 2, 2017
- Terminated
- May 11, 2017
- Product code
- KNW – Instrument, Biopsy
- Quantity
- 180 units
- Distribution
- Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
- Recalling firm
- Medtronic Advanced Energy, LLC, Portsmouth, NH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1126-2017 Class II | Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable…Product sterility compromised due to breach of sterile barrier | 12/28/2016Terminated |
| Z-1127-2017 Class II | Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Disposable…Product sterility compromised due to breach of sterile barrier | 12/28/2016Terminated |
| Z-1129-2017 Class II | Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable…Product sterility compromised due to breach of sterile barrier | 12/28/2016Terminated |
| Z-1130-2017 Class II | Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable…Product sterility compromised due to breach of sterile barrier | 12/28/2016Terminated |
| Z-1131-2017 Class II | Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable…Product sterility compromised due to breach of sterile barrier | 12/28/2016Terminated |
| Z-1132-2017 Class II | Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm Disposable…Product sterility compromised due to breach of sterile barrier | 12/28/2016Terminated |
| Z-1133-2017 Class II | Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable…Product sterility compromised due to breach of sterile barrier | 12/28/2016Terminated |
| Z-1134-2017 Class II | Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Disposable…Product sterility compromised due to breach of sterile barrier | 12/28/2016Terminated |
| Z-1135-2017 Class II | Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm Disposable…Product sterility compromised due to breach of sterile barrier | 12/28/2016Terminated |
| Z-1136-2017 Class II | Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Disposable…Product sterility compromised due to breach of sterile barrier | 12/28/2016Terminated |