| Class 2 Device Recall Medtronic Everest Disposable Inflation Device | |
Date Initiated by Firm | July 16, 2010 |
Date Posted | August 25, 2010 |
Recall Status1 |
Terminated 3 on June 07, 2011 |
Recall Number | Z-2271-2010 |
Recall Event ID |
56276 |
510(K)Number | K942269 K960983 |
Product Classification |
Balloon Inflation Syringe - Product Code MAV
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Product | Medtronic Everest 20 Disposable Inflation Device, AC2200.
Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon. |
Code Information |
Lot numbers: 50517330, 50517331,50517332, 50517333, 50517334, 50519716, 50519717, 50519718, and 50519679. |
Recalling Firm/ Manufacturer |
Medtronic, Inc. 35-37A Cherry Hill Drive Danvers MA 01923-2565
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For Additional Information Contact | Same 978-777-0042 |
Manufacturer Reason for Recall | Product sterility may be compromised due to breach of package seal integrity. |
FDA Determined Cause 2 | Packaging process control |
Action | 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. |
Quantity in Commerce | 2,875 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MAV
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