CATH. GUIDE 8F SR3.5 W/SH LAUN CATHETER LA8SR35SH LA 8F 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: LA8SR35SH
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-0989-06
- Quantity
- 52 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: 0000052427 0000063888 0000099509 220162 222827 224805
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.
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