CATH. GUIDE 8F FR4.0 W/SH 110C 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: Z28FR40SHA
FDA Recall Z-1045-06 · Posted 2006-06-01
Recalling FirmMedtronic, Inc.
Recall StatusTerminated
Product CodeDQY
Date Initiated2006-04-05
Date Terminated2007-06-20
Product Quantity16 units
Reason for Recall
Potential for non-sterility due to loss of package integrity
Firm Action
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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.