ZM5SR35 5F ZUMA SR3.5 CATHETER ZM5SR35 Z2 5F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM5SR35
This recall has been terminated (originally issued June 1, 2006).
- Company
- Medtronic, Inc.
- Recall Initiated
- April 5, 2006
- Posted
- June 1, 2006
- Terminated
- June 20, 2007
- Recall Number
- Z-1055-06
- Quantity
- 22 units
- Firm Location
- Danvers, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for non-sterility due to loss of package integrity
Distribution
Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.
Lot / Code Info
Lot Numbers: 0000004321 0000016470
Root Cause
Other
Action Taken
Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
More recalls by Medtronic, Inc.
Medtronic Everest 30 Disposable Inflation Device, AC3200.
Used to inflate/deflate balloon catheter...
Aug 25, 2010
Medtronic Everest 30 Disposable Inflation Device, AC3205P.
Used to inflate/deflate balloon cathete...
Aug 25, 2010
Medtronic Everest 20 Disposable Inflation Device, AC2200.
Used to inflate/deflate balloon catheter...
Aug 25, 2010