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Terminated

CATHETER SA63DRC SA 6F 100CM 3 CATHETER SA63DRC SA 6F 100CM 3DRC 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 Number: SA63DRC

FDA Recall Z-0996-06 · Posted 2006-06-01

Recalling FirmMedtronic, Inc.
Recall StatusTerminated
Product CodeDQY
Date Initiated2006-04-05
Date Terminated2007-06-20
Product Quantity110 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.

K021256Z3 GUIDE CATHETERMedtronic Vascular · 2002-05-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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