Recall Z-2272-2010
Medtronic, Inc. · initiated July 16, 2010
Product
Medtronic Everest 30 Disposable Inflation Device, AC3200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
Codes / lots: Lot numbers: 50517324.
Reason for recall
Product sterility may be compromised due to breach of package seal integrity.
FDA-determined cause: Packaging process control
Action taken
Medtronic issued a Urgent Medical Device Recall Notice to US customer on 7/15/2010 and to foreign accounts advising of the issue and requesting that they segregate recalled product. A Medtronic Sales Rep will visit their facility to account for all affected product and initiate a credit. Foreign accounts will return product to their respective distribution centers.
Details
- Recall number
- Z-2272-2010
- Initiated
- July 16, 2010
- Posted by FDA
- August 25, 2010
- Terminated
- June 7, 2011
- Product code
- MAV – Syringe, Balloon Inflation
- Quantity
- 768 units
- Distribution
- Worldwide Distribution -- USA, including the state of MI and the countries of Austria, Belgium, Czech Republic, Finland, France, Germany, Greece, Ireland, Israel, Italy, Lithuania, Pakistan, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, Ukraine, United Arab Emirates, and United Kingdom.
- Recalling firm
- Medtronic, Inc., Danvers, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2271-2010 | Medtronic Everest 20 Disposable Inflation Device, AC2200. Used to inflate/deflate…Product sterility may be compromised due to breach of package seal integrity. | 07/16/2010Terminated |
| Z-2273-2010 | Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate…Product sterility may be compromised due to breach of package seal integrity. | 07/16/2010Terminated |